Palindrome 8888145044CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521158085), received between Sep 6, 2018 and May 29, 2025 — classified as 2 deaths, 11 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Migration” (13 reports).

2 FDA recall records name this device's identifier, 2 still open.

47 other recalls cover devices cleared under the same FDA submission (K123196); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 15, 2024Class IIOpen, Classified

   Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating

   Z-1635-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1313-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE TREATMENT, THE VENOUS (BLUE) LUER ADAPTER WAS FOUND TO BE BROKEN, WITH VISIBLE CRACKS AND LEAKAGE. THE CATHETER WAS NOT REPAIRED. THE TEGO WAS NOT UTILIZED. THE PATIENT WAS NOT TREATED UNDER GENERAL OR LOCAL ANESTHESIA. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS UNREMARKABLE. OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE INCLUDED CIRCUITS AND EXTENSIONS. THE CUSTOMER WAS USING A COMPETITOR'S EXTENSION LINES WITH THE CATHETER AND A COMPETITOR'S CAPS. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS OCTENISEPT, WHICH WAS ALSO TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. THE DEVICE WAS LOOSENED/TIGHTENED MANUALLY BY HAND. LAVANIDE WAS IN DEMAND FOR OINTMENT, WHICH WAS UTILIZED AT THE EXIT SITE. THE WOUND DRESSING DOES NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES.THE CLEANING AGENTS ARE ALLOWED TO DRY COMPLETELY BEFORE OINTMENT APPLICATION. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY BEFORE THE AREA WAS DRESSED. THE PATIENTS ARE NOT RESPONSIBLE FOR CATHETER MAINTENANCE, CLEANING, OR DRESSING CHANGES. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111273 ↗
• MalfunctionMay 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE DIALYSIS TREATMENT, THE REPORTED PRODUCT HAD A BROKEN VENOUS ADAPTER. A CRACK WAS ALSO FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE CUSTOMER WAS USING CIRCUITS AND THE COMPETITOR¿S EXTENSION LINES WITH THE DEVICE. THE CUSTOMER WAS ALSO USING THE WHITE COMPETITOR¿S CAPS. THE PATIENT WAS NOT TREATED UNDER GENERAL OR LOCAL ANESTHESIA. THE CATHETER HAS BEEN IN PLACE FOR 12 MONTHS. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS UNREMARKABLE. OCTENISEPT WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS ALSO THE CLEANING AGENT TYPICALLY USED TO CLEAN THE CATHETER IN ITS ENTIRETY. LAVANID WAS THE OINTMENT UTILIZED AT THE EXIT SITE WHENEVER NECESSARY. LEUKOMED PATCHES WERE THE WOUND DRESSINGS UTILIZED. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT AND DRESSING THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE CLEANING, DRESSING CHANGES, ETC. THE CLEANING AGENT WAS NEVER SWITCHED OVER THE L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096422 ↗
• MalfunctionAug 6, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON(B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. THE LINE SITE AND DRESSING WERE IN APPALLING CONDITION. THE DRESSING WAS LOOS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921156 ↗
• InjuryAug 6, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. DURING THIS TIME, THE CUFF WAS OUT, AND THE LINE WAS USED IN A VERY POSITION

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hyperkalemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921070 ↗
• InjuryAug 6, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. IT HAD POOR FLOW, AND THE ARTERIAL LUMEN WAS DIFFICULT TO ASPIRATE. THE LINE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Hyperkalemia; Limb Pain; No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 19921053 ↗
• InjuryAug 6, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON MAY 18, 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. DURING THIS TIME, THE CUFF WAS OUT AND THE LINE WAS USED IN A VERY POSITION

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hyperkalemia; Hyperphosphatemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921047 ↗
• MalfunctionAug 6, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THEHOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. DURING THE TIME THE CUFF WAS OUT AND THE LINE WAS USED, FLOWS WERE FREQUENTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920218 ↗
• MalfunctionAug 5, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THEHOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. DURING THE TIME THE CUFF WAS OUT AND THE LINE WAS USED, FLOWS WERE FREQUENTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906873 ↗
• MalfunctionAug 5, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THEHOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. DURING THIS TIME, THE CUFF WAS OUT, AND THE LINE WAS USED. THEY WERE ADVISED

  Patient problems: Insufficient Information

  MAUDE report 19906639 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT WITH END-STAGE RENAL DISEASE DUE TO PROBABLE IGA NEPHROPATHY STARTED HEMODIALYSIS IN (B)(6) 2022. EXPLANTATION OF AN EXHAUSTED BRACHIOAXILLARY GRAFT OCCURRED ON (B)(6) 2024, NECESSITATING A TUNNELED LINE TO CONTINUE DIALYSIS. THE LINE WAS NOTED TO BE RED, WITH SOME DISCHARGE ON (B)(6), 2024; SWABS TAKEN; AND NO GROWTH. THE CATHETER WAS IN PLACE FOR 49 DAYS. STANDARD CLEANING OF DIALYSIS CATHETERS IN THE UNIT WAS DONE WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THEY WERE UNSURE OF THE EXACT DATE THEY STARTED USING CLINELL WIPES AS STANDARD CLEANING FOR DIALYSIS CATHETERS, BUT THEY HAD BEEN USING THEM FOR AT LEAST 7 OR 8 YEARS. THE CONTENTS AND COMPONENTS OF THE WIPES WERE 2% CHLORHEXIDINE AND 70% ALCOHOL. THE SCRUB USED THE HUB PROTOCOL. THE ENDS OF THE DIALYSIS CATHETER WERE UNWRAPPED FROM THEIR GAUZE AND PLACED ON A STERILE FIELD. THE NURSE PERFORMED HAND HYGIENE AND WOULD DON STERILE GLOVES BEFORE USING THE WIPES TO CLEAN THE DEADENDERS AND THE WHOLE OF EACH LUMEN (INCLUDING THE CLAMPS) UP TO THE EDGE OF THE DRESSING. ONE WIPE WAS USED PER LUMEN, AND THEY WERE CLEANED SIMULTANEOUSL

  Patient problems: Unspecified Infection

  MAUDE report 19817610 ↗
• InjuryJul 24, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH END-STAGE RENAL DISEASE DUE TO PROBABLE IGA NEPHROPATHY STARTED HEMODIALYSIS IN (B)(6) 2022. EXPLANTATION OF AN EXHAUSTED BRACHIOAXILLARY GRAFT OCCURRED ON (B)(6) 2024, NECESSITATING A TUNNELED LINE TO CONTINUE DIALYSIS. AT THE END OF PATIENT DIALYSIS, THE PATIENT'S ARTERIAL PRESSURE WAS ALARMING PRESSURES "++++". ON INSPECTION, THEY NOTICED BLOOD TRICKLING DOWN THE BELLY. ON FURTHER INSPECTION, THE CVC (CENTRAL VENOUS LINE) LINE WAS HANGING OUT; THE CUFF WAS ALREADY OUT. FLUSHING WAS DONE PRIOR TO USE, AND THE PATIENT MANAGED MOST OF THE DIALYSIS SESSION BEFORE THE LINE DISLODGED. NO OTHER DEFECTS OR DAMAGE WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. STANDARD CLEANING OF DIALYSIS CATHETERS IN THE UNIT WAS DONE WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THEY WERE UNSURE OF THE EXACT DATE THEY STARTED USING CLINELL WIPES AS STANDARD CLEANING FOR DIALYSIS CATHETERS, BUT THEY HAD BEEN USING THEM FOR AT LEAST 7 OR 8 YEARS. THE CONTENTS AND COMPONENTS OF THE WIPES WERE 2% CHLORHEXIDINE AND 70% ALCOHOL. THE SCRUB USED THE HUB PROTOCOL. THE ENDS O

  Patient problems: Insufficient Information

  MAUDE report 19817574 ↗
• MalfunctionJul 22, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. THE LINE WAS USED, AND THE PATIENT HAD ROUTINE HD (HEMODIALYSIS) WITH THIS V

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799732 ↗
• InjuryJul 22, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6)2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THEHOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. THE PATIENT PRESENTED FOR THE USUAL DIALYSIS SESSION ON (B)(6) 2024, AND NURSI

  Patient problems: Rash; Unintended Radiation Exposure

  MAUDE report 19798755 ↗
• InjuryJul 22, 2024Migration; Migration

  ACCORDING TO THE REPORTER, A PATIENT WITH PARATHYROIDECTOMY, PARATHYROID ADENOMA, NEPHROCALCINOSIS, HYPERCALCAEMIC NEPHROPATHY, CKD4 (STAGE 4 CHRONIC KIDNEY DISEASE), AND PERSONALITY DISORDER HAD STARTED HEMODIALYSIS WITH A NO-KNOWN-ISSUE TEMPORARY JUGULAR LINE ON (B)(6) 2022, WITH POOR COMPLIANCE WITH THE DIALYSIS SCHEDULE AND MEDICATIONS. THE PATIENT WOULD FREQUENTLY NOT ATTEND DIALYSIS SESSIONS; THE PATIENT HAD BEEN KNOWN TO MISS TWO WEEKS WORTH OF SESSIONS IN A ROW. THE PATIENT HAD BEEN EDUCATED MULTIPLE TIMES ON THE POTENTIAL CONSEQUENCES OF MISSING DIALYSIS, BUT IT WAS DIFFICULT TO GET THE PATIENT TO ENGAGE. THE PATIENT ENDED UP COMING INTO THE HOSPITAL THROUGH THE EMERGENCY DEPARTMENT IN EXTREMIS AFTER MISSING MANY SESSIONS. THE PATIENT WOULD BE OFFERED MULTIPLE APPOINTMENTS FOR LINE EXCHANGES BUT WOULD NOT SHOW UP. THE PATIENT WOULD FREQUENTLY DISCHARGE HIMSELF FROM THE HOSPITAL AGAINST MEDICAL ADVICE OR ABSCOND FROM THE WARD. THE PATIENT WAS ELECTED NOT TO HAVE AN AV (ATRIAL VENOUS) FISTULA CREATED. SOMETIMES THE PATIENT WOULD CHOOSE TO ENGAGE WITH THE SERVICE, AND SOMETIMES THE PATIENT WOULD NOT. THE LINE CAME OUT COMPLETELY ONE HOUR INTO DIALYSIS SESSION ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19798379 ↗
• MalfunctionFeb 26, 2024Break; Break

  ACCORDING TO THE REPORTER, THE 23 CENTIMETER CATHETER WAS IMPLANTED INTO THE PATIENT AND DURING THE REMOVAL OF THE CATHETER, THE CATHETER SHAFT WAS TORN (BROKE) AT THE ATTACHMENT PIECE AND HAD TO BE REMOVED ON THE SAME DAY OF THE EVENT AND REPLACED WITH ANOTHER MODEL TO RESOLVE THE ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. FLUSHING WAS NOT PERFORMED. SEPSIDERM WAS NOT USED TO CLEAN CATHETER AND THERE WAS NO CHANGE IN PROTOCOL FOR THE CLEANING AGENTS USED RECENTLY. THERE WERE NO CURRENT AND PRE-EXISTING CONDITIONS OF THE PATIENT THAT MAY BE RELATED TO THE EVENT. THE PATIENT HAD NO FURTHER COMPLICATIONS AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777207 ↗
• InjuryFeb 15, 2024Product Quality Problem; Difficult to Remove; Unraveled Material; Insufficient Flow or Under Infusion; Product Quality Problem; Difficult to Remove; Unraveled Material; Insufficient Flow or Under Infusion

  ACCORDING TO THE REPORTER, THERE WAS PLACEMENT OF A CATHETER IN THE ¿RIGHT INTERNAL JUGULAR D¿ WITHOUT FORESEEABLE DIFFICULTY IN A PATIENT WHO HAD PREVIOUSLY RECEIVED ¿VVC¿ IN THE PAST AND ALREADY BENEFITED FROM A CENTRAL VENOUS LINE WITHOUT VISIBLE STENOSIS. WHEN THE VEIN WAS PUNCTURED, THERE WAS A FAILURE TO DESCEND THE GUIDEWIRE, PROBABLY DUE TO THE NEEDLE COMING OUT OF THE VEIN. THE GUIDEWIRE OF THE REPORTED 23 CENTIMETERS (CM) CATHETER KIT WAS DAMAGED/DETERIORATED FOLLOWING THIS STEP BECAUSE IT GOT STUCK IN THE BEVEL OF THE NEEDLE AND WAS DAMAGED WHEN RELEASED. THEREFORE, A COMPETITOR HYDROPHILIC RADIFOCUS GUIDE WIRE M WITH A LENGTH OF 180 CENTIMETER (CM) AND A DIAMETER OF 0.89 MILLIMETERS (MM) WAS USED. THE PUNCTURE WAS CARRIED OUT WITHOUT DIFFICULTY AND THE GUIDE WAS LOWERED. AT THIS STAGE OF THE INSTALLATION, FLUOROSCOPY (RADIOSCOPY) WAS NOT USED IN THE ABSENCE OF FORESEEABLE DIFFICULTY. THE CATHETER WAS THEN TUNNELED RETROGRADE, THE JUGULAR SITE WAS PREPARED FOR DILATION OF THE VEIN AND THEN THE DESCENT OF THE DILATORS BEGUN. THE FIRST DILATOR OF SMALL CALIBER DESCENDED WITHOUT DIFFICULTY OR PAIN. WHEN THE SECOND DILATOR WAS PLACED, A RESISTANCE WAS REPORTED. AFTER INSPECT

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18712907 ↗
• InjuryDec 18, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PATIENT HAD A LINE PLACED ON (B)(6) 2020, WITH NO ISSUES. AFTER 3 YEARS, 6 MONTHS, AND 15 DAYS OF INSERTION, ON THE DAY OF THE EVENT, THE PATIENT ATTENDED DIALYSIS; HOWEVER, 1 HOUR INTO THE DIALYSIS SESSION, THE PATIENT NOTICED SOME BLOOD SPOTS ON THEIR T-SHIRT. THEY CALLED THE NURSE, AND THE NURSE APPROACHED TO HAVE A LOOK, AND BLOOD SPRAYED EVERYWHERE WHEN THELINE WAS TOUCHED. A SMALL HOLE WAS NOTED WHERE THE VENOUS LUMEN AND THE WING MET, WHICH POSED A HIGH RISK OF AIR EMBOLISM AND INFECTION. THE HEMODIALYSIS (HD) MACHINE WAS STOPPED INSTANTLY, AND THE REPORTER WAS CALLED. ON THE REPORTER'S ARRIVAL, THE PATIENT BEGAN TO FEEL BREATHLESS AND COMPLAINED OF PAIN, NUMBNESS, AND PINS AND NEEDLES DOWN THEIR LEFT ARM. THE PATIENT WAS SUFFERING FROM THE REPORTED CLINICAL SIGNS/SYMPTOMS/CONDITIONS FROM (B)(6) 2023. THE CLAMP WAS MOVED PERIODICALLY. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO ISSUES WERE NOTED PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND NO ISSUES WERE NOTED. CLINELL AND CHLORAPREP WERE CLEANING AGENTS USED ON THE DEVICE. CLINELL WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED

  Patient problems: Air Embolism; Dyspnea; Hemorrhage/Blood Loss/Bleeding; Numbness; Pain; Unintended Radiation Exposure

  MAUDE report 18352701 ↗
• MalfunctionJul 3, 2023Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  ACCORDING TO THE REPORTER, THE LINE CUFF WAS OUT AND FELL OUT. IT WAS REMOVED BY THE RENAL DOCTOR. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 17252932 ↗
• InjuryJul 3, 2023Migration; Migration

  ACCORDING TO THE REPORTER, DURING POST DIALYSIS AT HOME, THE CATHETER LINE FELL OUT AT HOME. THE DEVICE PARTIALLY MOVED OUT OF PLACE. THERE WAS NO LEAK AND TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE AND THE CATHETER WAS NOT REPAIRED. CHLORAPREP WAS THE CLEANING AGENT USED ON THE DEVICE. FLUSHING WAS NOT PERFORMED PRIOR TO USE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THERE WERE NO DAMAGES NOTED ON THE PRODUCT. THERE WAS NO SECUREMENT WING ISSUE AND THERE WAS NO CLOTHING FACTOR THAT MIGHT HAVE NOT CONTRIBUTED TO THE EVENT. THE CATHETER WAS MAINTAINED IN PLACE BY SUTURES AND DRESSING. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE SECOND LINE WAS INSERTED ON THE SAME DAY. IT WAS MENTIONED THAT LINE WAS REMOVED, ANTIBIOTIC COVER, BLOOD WAS TAKEN AS THE REMEDIAL ACTION DONE TO RESOLVE THE ISSUE. ON MAY 31, 2023, THE LINE CUFF WAS OUT AND FELL OUT AND IT WAS REMOVED BY THE RENAL DOCTOR. THE PATIENT HAD NO FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 17247562 ↗
• InjuryMay 5, 2023Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, PATIENT WAS ADMITTED WITH STAPHYLOCOCCUS AUREUS BACTERAEMIA (SAB) UNDERGOING TREATMENT WHEN IT WAS NOTICED THERE WAS A PROBABLE HOLE IN DIALYSIS CATHETER, THIS WAS DETECTED AS AIR IN DIALYSIS MACHINE. USE WAS DISCONTINUED, PATIENT INFORMED THE ISSUE, AND TCVC (TUNNELED CENTRAL VENOUS CATHETER) WAS REMOVED THAT SAME DAY FOR SAFETY. PATIENT HAD REOCCURRING SAB SINCE AND PATIENT TREATED WITH ANTIBIOTICS. PATIENT WAS NOW BEING TREATED FOR ENDOCARDITIS AND WOULD NEED HEART VALVE REPLACEMENT.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 16882167 ↗
• DeathNov 4, 2022Break; Break

  ACCORDING TO THE REPORTER, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. THE DIALYSIS TREATMENT WAS STOPPED. THE PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 15735324 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE LINE WAS REPLACED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715414 ↗
• MalfunctionNov 2, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE LUER ADAPTER BROKE/CRACKED WHILE USING TEGO. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. ALCOHOL AS PER IFU (INSTRUCTION FOR USE) WAS THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE DEVICE AND THE ADAPTER ITSELF. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. HAND WAS UTILIZED TO TIGHTEN THE ADAPTERS. TEGO WAS BEING UTILIZED WITH THE DEVICE. IT WAS SAID THAT THERE WERE BLOOD LEAK/LOSS FROM THE CRACK ON THE LUER ADAPTER BUT DROPS ONLY. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT HAD NO MEDICAL INTERVENTION/TREATMENT DUE TO THE EVENT. THE CATHETER WAS REPAIRED. TREATMENT WAS STILL COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714021 ↗
• MalfunctionAug 23, 2022Break; Break

  ACCORDING TO THE REPORTER, BEFORE DIALYSIS, IT WAS NOTED THAT THE CATHETER¿S ARTERIAL LUER ADAPTER (RED) WAS TORN AND THE VENOUS LUER ADAPTER (BLUE) BROKE OUT. THE CATHETER WAS IN PLACE FOR 3 YEARS AND 7 MONTHS. THERE WAS NO LEAK, THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE USE, AND IT WAS FLUSHED PRIOR TO USE AND THE OUTCOME WAS NORMAL. THE CLEANING AGENT USED ON THE DEVICE IS OCTENISEPT, OCTENISEPT WAS ALSO THE CLEANING AGENT TYPICALLY USED TO CLEAN THE ADAPTERS (WHETHER IT DRY ALWAYS IN ANY CASE IS UNKNOWN), AND THE CLEANING AGENT EXPOSURE TIME WAS ONE MINUTE (WHETHER IT ALWAYS DRIED IN ANY CASE WAS UNKNOWN) BEFORE APPLYING THE OINTMENT TO THE AREA. THE ADAPTERS WAS TIGHTEN MANUALLY, NO OTHER PRODUCT WAS USED WITH THE DEVICE, NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE AND NO INTERVENTION/TREATMENT WAS REQUIRED DUE TO THE ADAPTER ISSUE. THE FOLLOWING WEEK THE CATHETER WAS REPAIRED WITH A REPAIR KIT. IT WAS STATED THAT AS A REMEDIAL ACTION IT WAS SUPPLIED WITH TEGO (TEGO WAS UTILIZED). THE PROCESS WAS CONTINUED AND COMPLETED AFTER THE CORRECTIVE ACTION WAS TAKEN. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO BLOOD LOSS AND BL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278942 ↗
• MalfunctionAug 23, 2022Break; Break

  ACCORDING TO THE REPORTER, BEFORE DIALYSIS IT WAS NOTED THAT THE CATHETER¿S VENOUS LUER ADAPTER (BLUE) PIECE WAS BROKEN (HAD A CRACK AT THE END). THERE WAS NO LEAK, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE BEFORE USE, AND IT WAS FLUSHED PRIOR TO USE AND EVERYTHING WAS NORMAL. THE CLEANING AGENT USED ON THE DEVICE WAS OCTENISEPT, OCTENISEPT WAS ALSO TYPICALLY USED TO CLEAN THE ADAPTERS, AND THE CLEANING AGENT HAD 1 MINUTE EXPOSURE TIME (UNABLE TO GUARANTEE THAT IT WAS DRY) BEFORE APPLYING THE OINTMENT. THE LUER ADAPTER WAS MANUALLY TIGHTENED, NO OTHER PRODUCTS WERE USED WITH THE DEVICE, NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE, AND NO INTERVENTION/TREATMENT WAS REQUIRED DUE TO ADAPTER ISSUE. THE REPORTED CATHETER REMAINS IN THE PATIENT (IMPLANTED) AND CANNOT BE REPAIRED BECAUSE THERE WAS NO REPAIR KIT AVAILABLE. TEGO WAS UTILIZED AS A CORRECTIVE ACTION. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE CORRECTIVE ACTION WAS TAKEN. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277708 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123196. One submission often covers many models, so check the product and lot details in each record.

• Z-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1634-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute a
• Z-1314-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1312-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1315-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-2375-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
• Z-2372-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
• Z-2373-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
• Z-2374-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
• Z-2371-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
• Z-0333-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic cat

…and 32 more.