PRISMAFLEX SET HF1400Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07332414069315), received between Feb 22, 2018 and Sep 30, 2026 — classified as 2 deaths, 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K042938); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 6, 2026Open, Classified

   There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

   Z-1230-2026 · Root cause: Component design/selection · FDA record ↗

2. Sep 14, 2022Open, Classified

   Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

   Z-0083-2023 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately fifteen (15) minutes after initiation of continuous renal replacement therapy (CRRT) using Prismaflex HF set, a patient experienced severe hypotension requiring up to three (3) vasopressors. Anallergic reaction was suspected. After switching to Prismaflex ST set, the hypotensive episodes reportedly did not recur. It is further reported that the patient passed away, however, the date and cause of death were not provided. No additional information is available.

  Patient problems: Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension

  MAUDE report 50951729 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTERNAL BLOOD LEAK WAS OBSERVED DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH FOUR (4) PRISMAFLEX HF 1400 SETS, WHICH "AFFECTED ONE PATIENT". THE SET WAS REPLACED TO CONTINUE TREATMENT WITH A SET FROM A DIFFERENT PRODUCT LOT. NO INFORMATION WAS PROVIDED TO CONFIRM WHETHER THE EXTRACORPOREAL BLOOD WAS RETURNED TO THE PATIENT. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072349 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE DRAIN BAG OF TWO (2) PRISMAFLEX HF1400 SETS PRIOR TO USE FOR THERAPY. THE BAGS WERE "NOT PROPERLY SEALED ". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575240 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak

  BRAND NEW CVVH [CONTINUOUS VENO-VENOUS HEMOFILTRATION] SET-UP WITH THE PRISMAX AUTO-EFFLUENT ACCESSORY KIT FOUND LEAKING AT THE BOTTOM OF THE DRAIN BAG WHERE THE TUBING DRAIN IS CONNECTED (CLOSED SYSTEM, NON-LUER LOCK TUBING CONNECTION). THIS HAS BEEN A RECURRING ISSUE WITH THESE DRAINS (NOT NECESSARILY FOR SAME PATIENT). THIS IS IN REFERENCE TO ITEM LOT #24C1101 (REF #115370). THE ENTIRE FILTER SET-UP IS WASTED, AND A BRAND-NEW FILTER HAD TO BE USED, WHICH TAKES AT LEAST 30 MINUTES TO SET UP, WHICH DELAYS THE TREATMENT FOR THIS PATIENT.

  Patient problems: Therapy/non-surgical treatment/delayed/prolonged

  MAUDE report 22893944 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT IS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION OF A PRISMAFLEX HF1400 SET DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872079 ↗
• MalfunctionAug 21, 2025Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT A PRISMAFLEX HF1400 SET WAS OBSERVED TO HAVE "COAGULATION ISSUES" DURING CONTINUOUS RENAL REPLACEMENT THERAPY. IN ADDITION, THE "PATIENT HAD GONE THROUGH 10 FILTERS IN THE LAST 2 DAYS DUE TO ACCESS ISSUES." THE VOLUME OF ASSOCIATED BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868007 ↗
• MalfunctionJun 19, 2025Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT AN "INEFFICIENT HEMOFILTRATION WAS OBSERVED DUE TO RAPID FILTER COAGULATION" DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAFLEX HF1400 SET. IT WAS ALLEGED THAT EIGHT (8) SETS WERE USED IN THREE (3) TO FOUR (4) DAYS AND "SEVERAL THERAPIES WERE INITIATED". THE VOLUME OF BLOOD LOSS WAS NOT KNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293985 ↗
• MalfunctionJan 8, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ACCESS LINE OF A PRISMAFLEX HF100 SET WAS "CRACKED" AND LEAKED BLOOD DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THE VOLUME OF BLOOD LOSS WAS UNKNOWN. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106004 ↗
• MalfunctionJan 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION OF A PRISMAFLEX HF1400 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080227 ↗
• MalfunctionNov 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE ACCESS MULTI CONNECTOR OF A PRISMAFLEX HF1400 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20709582 ↗
• MalfunctionApr 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A "HOLE" IN THE RETURN LINE ABOVE THE DEAERATION CHAMBER OF A PRISMAFLEX HF1400 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. FLUID WAS DRIPPING FROM THE TUBING. THE BLOOD WAS RETURNED TO THE PATIENT AND THE SET WAS REPLACED TO CONTINUE TREATMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076058 ↗
• MalfunctionMar 29, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION OF A PRISMAFLEX HF1400 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006912 ↗
• MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PRISMAFLEX HF1400 SET WAS LEAKING AT THE FOUR POINT CONNECTION OF THE RED ACCESS LINE PRIOR TO THE ENTRANCE OF THE BLOOD PUMP. THIS WAS DISCOVERED DURING PRIMING FOR HEMODIALYSIS TREATMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942197 ↗
• MalfunctionNov 7, 2023Fluid/Blood Leak; Protective Measures Problem; Air/Gas in Device; Fluid/Blood Leak; Protective Measures Problem; Air/Gas in Device

  IT WAS REPORTED AN ALARM-TREATMENT-AIR FOAM IN BLOOD TRIGGERED ON A PRISMAFLEX HF1400 SET. DURING CONTINUOUS RENAL REPLACEMENT THERAPY, THE MACHINE STARTED TO ALARM FOR AIR EVEN THOUGH NO AIR WAS PRESENT IN THE CIRCUIT. THERAPY WAS HALTED AND THE NURSE ATTEMPTED TO RETURN THE BLOOD; HOWEVER, THE NURSE WAS UNABLE TO RETURN THE CIRCUIT OF BLOOD. THE PATIENT WAS THEN DISCONNECTED, AND CIRCUIT LINES WERE CLAMPED TO REMOVE FROM THE PRISMAFLEX MACHINE. THE ALARM CONTINUED DURING REMOVAL OF THE FILTER SET SAYING, ¿PATIENT WAS STILL CONNECTED¿ AND SAYING, ¿LINES WERE NOT CLAMPED¿, EVEN THOUGH PATIENT WAS NOT CONNECTED TO MACHINE AND ALL CLAMPS ON FILTER SET WERE CLOSED. THE NURSE HAD TO OVERRIDE THE MACHINE TO REMOVE THE FILTER SET. THE LINES WERE RE-PRIMED, AND ALL CONNECTIONS WERE TRIPLE VERIFIED. AS SOON AS THERAPY WAS RESTARTED, AIR WAS OBSERVED BEING PULLED INTO THE MACHINE AT THE VASCATH SITE. THERAPY WAS AGAIN DISCONTINUED AND THE PATIENT WAS DISCONNECTED. THE ALARM AGAIN SHOWED ¿PATIENT WAS STILL CONNECTED¿ AND ¿LINES WERE NOT CLAMPED¿ EVEN THOUGH PATIENT WAS DISCONNECTED, AND ALL LINES WERE CLAMPED. THE MACHINE WAS REMOVED FROM SERVICE. THE PATIENT LOST 4 CIRCUITS OF BLOOD AT APPR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088127 ↗
• MalfunctionJul 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN EXTERNAL BLOOD LEAK WAS OBSERVED ORIGINATING FROM THE TUBING NEAR THE DEAERATION CHAMBER AT THE JUNCTURE WITH REPLACEMENT TUBING OF A PRISMAFLEX HF1400 SET DURING CONTINUOUS RENAL REPLACEMENT THERAPY VIA THE PRISMAX SYSTEM VERSION 2 WHICH WAS EQUIPPED WITH A THERMAX BLOOD WARMER. THE PRISMAX MACHINE SHUTDOWN DURING TREATMENT AFTER A SERVICE CALL ALARM OCCURRED. THE SET WAS REPLACED. IT WAS NOT REPORTED IF THE EXTRACORPOREAL BLOOD WAS RETURNED, NOR WAS IT REPORTED THE VOLUME OF BLOOD LOST. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393609 ↗
• InjuryMar 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMOLYSIS DURING TREATMENT WITH A PRISMAFLEX CONTROL UNIT, A PRISMAFLEX HF1400 AND A PRISMAFLEX M150. AT AN UNKNOWN TIME DURING TREATMENT WITH A PRISMAFLEX HF1400, THE EFFLUENT WAS OBSERVED TO BE PINK. A BLOOD LEAK DETECTED ALARM WAS NOT TRIGGERED BY THE CONTROL UNIT. THE SET WAS CHANGED TO A PRISMAFLEX M150. AT AN UNKNOWN TIME DURING THIS TREATMENT, THE EFFLUENT BAG WAS OBSERVED TO HAVE A "RED-BLOOD LOOKING COLOR". A BLOOD LEAK DETECTED ALARM WAS NOT TRIGGERED BY THE CONTROL UNIT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN NECESSITATING A BLOOD TRANSFUSION. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemolysis

  MAUDE report 11538884 ↗
• InjuryMar 22, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMOLYSIS DURING TREATMENT WITH A PRISMAFLEX CONTROL UNIT, A PRISMAFLEX HF1400 AND A PRISMAFLEX M150. AT AN UNKNOWN TIME DURING TREATMENT WITH A PRISMAFLEX HF1400, THE EFFLUENT WAS OBSERVED TO BE PINK. THE SET WAS CHANGED TO A PRISMAFLEX M150. AT AN UNKNOWN TIME DURING THIS TREATMENT, THE EFFLUENT BAG WAS OBSERVED TO HAVE A "RED-BLOOD LOOKING COLOR". A BLOOD LEAK DETECTED ALARM WAS NOT TRIGGERED BY THE CONTROL UNIT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN NECESSITATING A BLOOD TRANSFUSION. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hemolysis

  MAUDE report 11538880 ↗
• MalfunctionFeb 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN EXTERNAL BLOOD LEAK WAS OBSERVED DURING TREATMENT WITH A PRISMAFLEX HF1400 SET. IT WAS OBSERVED THAT THE BLUE RING CONNECTION ON THE RETURN LINE CONTINUOUSLY TURNED WHEN TIGHTENED LIKE THE THREADS WERE STRIPPED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368335 ↗
• MalfunctionOct 21, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DEFECT IN THE BLOOD PUMP SEGMENT OF A PRISMAFLEX HF1400, RESULTING IN A FLUID LEAK FROM THE CARTRIDGE. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10710363 ↗
• DeathFeb 3, 2020Disconnection; Improper or Incorrect Procedure or Method; Disconnection; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT WHO WAS BEING TREATED WITH CONTINUOUS RENAL REPLACEMENT THERAPY USING A PRISMAFLEX CONTROL UNIT, A PRISMAFLEX HF1400 FILTER SET AND A TEGO CONNECTOR (NON BAXTER DEVICE) "BLEED OUT" AND SUBSEQUENTLY PASSED AWAY. IT WAS REPORTED THAT IN ACCORDANCE WITH THE FACILITY CLINICAL PRACTICE, THE TEGO CONNECTOR (NON BAXTER DEVICE) WAS CONNECTED BETWEEN THE PATIENT CATHETER (NON BAXTER DEVICE) AND THE RETURN BLOOD LINES. TREATMENT HAD BEEN RUNNING FOR MORE THAN NINETEEN (19) HOURS WHEN THE RETURN BLOOD LINE BECAME DISCONNECTED FROM THE TEGO CONNECTOR. NO ALARM WAS GENERATED BY THE PRISMAFLEX CONTROL UNIT AS A RESULT OF THE DISCONNECTION. THE OPERATOR WAS ALERTED BY A CARDIAC MONITOR AS THE PATIENT PRESENTED WITH BRADYCARDIA AND THE PATIENT HAD ¿BLEED OUT¿. THE NURSE RESPONDED TO THE ALARM AND ASSESSED AIRWAY. THE RED AND BLUE LINES OF THE SET WERE CLAMPED AND THE MACHINE WAS STOPPED. THE ESTIMATED BLOOD LOSS WAS REPORTED AS APPROXIMATELY 150-200ML. THE PATIENT SUBSEQUENTLY PASSED AWAY. IT WAS REPORTED THAT AN AUTOPSY WILL BE PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 9662285 ↗
• MalfunctionDec 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX HF1400, AN EXTERNAL FLUID LEAK OCCURRED. IT WAS REPORTED THE TUBING WAS PULLED ON THE SMALL AUTO EFFLUENT BAG WHEN REMOVING IT FROM THE PACKAGING, CAUSING A LEAK IN THE BAG. TREATMENT WAS STARTED EVEN THOUGH THE FLUID WAS LEAKING. THERE WAS PATIENT INVOLVEMENT BUT NO ADVERSE EVENT OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483761 ↗
• MalfunctionDec 13, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX HF1400 THE PRE BLOOD PUMP BAG WAS NOT CONNECTED SECURELY AND BECAME DISCONNECTED, CAUSING A SIGNIFICANT AMOUNT OF AIR TO ENTER INTO THE EXTRACORPOREAL CIRCUIT LEADING TO FOAM FORMATION IN THE DEAERATION CHAMBER. BLOOD WAS RETURNED TO THE PATIENT AND THE MACHINE WAS PLACED INTO SALINE RECIRCULATION HOWEVER, THE DEAERATION CHAMBER WAS ALMOST COMPLETELY FILLED WITH FOAM AND THE FILTER CLOTTED ALARM STARTED OCCURRING. THE FLUID LEVEL IN THE CHAMBER WAS VERY LOW AND THE FOAM ENTERED THE MONITOR LINE AND REACHED THE TRANSDUCER FILTER. THERE WAS A SIGNIFICANT AMOUNT OF FOAM IN THE CIRCUIT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9467033 ↗
• InjuryAug 7, 2019Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PATIENT TREATMENT WITH A PRISMAFLEX HF1400 SET, THE ARTERIAL LUER LOCK CONNECTOR HAD BROKE OFF, AND WAS STUCK INSIDE THE Y-CONNECTOR THAT WAS CONNECTED TO NORMAL SALINE. THIS RESULTED IN AIR ENTERING THE PATIENT. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND WAS PLACED ON A VENTILATOR TO RELIEVE THE SYMPTOMS. THE PATIENT HAS RECOVERED WITH NO LASTING EFFECTS AND IS NOW BEING TREATED WITH ORDINARY DIALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Air Embolism

  MAUDE report 8868818 ↗
• MalfunctionJul 2, 2018Misassembled; Misassembled

  IT WAS REPORTED THAT THE PBP LINE AND THE EFFLUENT LINE WERE FOUND TO BE CROSSED ON A PRISMAFLEX HF1400 SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656430 ↗
• MalfunctionJun 14, 2018Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED THAT AN EXTERNAL LEAK OCCURRED ON A PRISMA FLEX HF1400 TUBING. THE LEAK WAS OBSERVED TO BE COMING FROM A PIN HOLE IN THE SET THAT RESULTED IN SALINE SQUIRTING OUT DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7601993 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042938. One submission often covers many models, so check the product and lot details in each record.

• Z-1229-2026 · Jan 6, 2026 · Open, Classified
  PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Z-0085-2023 · Sep 14, 2022 · Open, Classified
  Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
• Z-2379-2021 · Jul 22, 2021 · Terminated
  Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
• Z-2205-2014 · Jul 18, 2014 · Terminated
  Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Z-2204-2014 · Jul 18, 2014 · Terminated
  Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box