stay.safe® 050-95003Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840861100774), received between Oct 2, 2017 and Oct 15, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 other recalls cover devices cleared under the same FDA submission (K173593, K250404, K822550); 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. Jan 23, 2024Class IOpen, Classified

   The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

   Z-1324-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK ON THE FLOOR DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DWELL 3 OF 3 OF TREATMENT. THE WARNING OCCURRED MULTIPLE TIMES. THE PATIENT STATED THAT THE BAXTER BAG CAME LOOSE AND FLUID LEAKED ONTO THE FLOOR. THE PATIENT NOTED THAT THE BAXTER BAG WAS EMPTY. THE PATIENT ELECTED TO CONTINUE WITH TREATMENT UNLESS THE ALARM OCCURRED AGAIN. UPON FOLLOW UP, THE PATIENT STATED THAT THE ADAPTOR HAS A POOR DESIGN AND DOES NOT ATTACH TO THE BAXTER BAG PROPERLY. THE ADAPTOR FELL OFF DURING TREATMENT CAUSING THE BAXTER BAG TO LEAK ALL OVER HIS FLOOR. THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE ADAPTOR WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302897 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED A PATIENT THAT WAS DIAGNOSED WITH PERITONITIS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WAS SEEN IN THE PD CLINIC ON 25/APR/2024 FOR A REGULARLY SCHEDULED PERITONEAL EQUILIBRATION TEST (PET). UPON ARRIVAL, IT WAS NOTED THAT THE PATIENT DID NOT HAVE A PIN IN THE EXTENSION SET. THE PATIENT STATED THAT HE PINNED AT THE END OF TREATMENT; HOWEVER, THE PDRN STATED THE PATIENT HAS BEEN VERY FORGETFUL RECENTLY. ADDITIONALLY, THE PD EFFLUENT WAS NOTED TO BE CLOUDY. A PD CULTURE WAS OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND ADMINISTERED INTRAPERITONEAL (IP) VANCOMYCIN 2G. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH IP CEFTAZIDIME DAILY (DOSE AND DURATION NOT PROVIDED). THE CULTURE CAME BACK POSITIVE ON 29/APR/2024 FOR PSEUDOMONAS AERUGINOSA. THE PHYSICIAN DISCONTINUED THE CEFTAZIDIME AND ORDERED IP CEFEPIME 2G DAILY FOR 21 DAYS STARTING 30/APR/2024. THE PATIENT IS SCHEDULED FOR A CLINIC VISIT ON 02/MAY/2024 TO HAVE THE EXTENSION SET CHANGED. REPEAT CULTURES WILL BE OBTAINED AFTER THE COMPLETION OF THE ANTIBIOTIC THERAPY. THE PDRN STATED THE CAUSE OF THE PERITONITIS WAS SELF-

  Patient problems: Peritonitis

  MAUDE report 19300786 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED A PATIENT THAT WAS DIAGNOSED WITH PERITONITIS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PDRN. THE PATIENT WAS SEEN IN THE PD CLINIC ON (B)(6) 2024 FOR A REGULARLY SCHEDULED PERITONEAL EQUILIBRATION TEST (PET). UPON ARRIVAL, IT WAS NOTED THAT THE PATIENT DID NOT HAVE A PIN IN THE EXTENSION SET. THE PATIENT STATED THAT HE PINNED AT THE END OF TREATMENT; HOWEVER, THE PDRN STATED THE PATIENT HAS BEEN VERY FORGETFUL RECENTLY. ADDITIONALLY, THE PD EFFLUENT WAS NOTED TO BE CLOUDY. A PD CULTURE WAS OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND ADMINISTERED INTRAPERITONEAL (IP) VANCOMYCIN 2G. THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY WITH IP CEFTAZIDIME DAILY (DOSE AND DURATION NOT PROVIDED). THE CULTURE CAME BACK POSITIVE ON (B)(6) 2024 FOR PSEUDOMONAS AERUGINOSA. THE PHYSICIAN DISCONTINUED THE CEFTAZIDIME AND ORDERED IP CEFEPIME 2G DAILY FOR 21 DAYS STARTING (B)(6) 2024. THE PATIENT IS SCHEDULED FOR A CLINIC VISIT ON (B)(6) 2024 TO HAVE THE EXTENSION SET CHANGED. REPEAT CULTURES WILL BE OBTAINED AFTER THE COMPLETION OF THE ANTIBIOTIC THERAPY. THE PDRN STATED THE CAUSE OF THE PERITONITIS WAS SELF-

  Patient problems: Peritonitis

  MAUDE report 19300447 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE PATIENT¿S CATHETER DURING THEIR PD TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PDRN STATED THAT THE CAUSE OF THE LEAK WAS A HOLE IN THE PLASTIC ADAPTER. THE PATIENT WAS SEEN IN THE CLINIC WHERE THE TUBING OF THE ADAPTER WAS CUT AND REPLACED. CONFIRMED THAT FLUID DID NOT COME IN CONTACT WITH THE CYCLER. PER THE CLINIC¿S PROCEDURE THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS, CEPHALEXIN (250 MILLIGRAMS, ORAL, THREE TIMES A DAY FOR THREE DAYS) CONFIRMED THAT DESPITE THE PROPHYLACTIC ANTIBIOTICS, THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUIRING MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. CONFIRMED THAT THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE ADAPTER USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298928 ↗
• MalfunctionNov 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) REPORTED THAT THE CONNECTOR TO THE BAXTER WAS LOOSENED AND A FLUID LEAK OCCURRED. THE PATIENT STATED THAT THEY HANG THEIR BAG ON THE SIDE OF THE CART AND THAT THERE IS A FLAW IN THE CONNECTOR, POSSIBLY THE BAXTER END. THE PATIENT BEGUN TAPING THE CONNECTOR SO THAT IT DOES NOT OPEN. THE NURSE STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED TREATMENT ON THE CYCLER. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE PATIENT WAS NOT SYMPTOMATIC AND WAS NOT TREATED WITH ANTIBIOTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9368481 ↗
• MalfunctionNov 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) REPORTED THAT THE CONNECTOR TO THE BAXTER WAS LOOSENED AND A FLUID LEAK OCCURRED. THE PATIENT STATED THAT THEY HANG THEIR BAG ON THE SIDE OF THE CART AND THAT THERE IS A FLAW IN THE CONNECTOR, POSSIBLY THE BAXTER END. THE PATIENT BEGUN TAPING THE CONNECTOR SO THAT IT DOES NOT OPEN. THE NURSE STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED TREATMENT ON THE CYCLER. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE PATIENT WAS NOT SYMPTOMATIC AND WAS NOT TREATED WITH ANTIBIOTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9368460 ↗
• MalfunctionNov 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) REPORTED THAT THE CONNECTOR TO THE BAXTER WAS LOOSENED AND A FLUID LEAK OCCURRED. THE PATIENT STATED THAT THEY HANG THEIR BAG ON THE SIDE OF THE CART AND THAT THERE IS A FLAW IN THE CONNECTOR, POSSIBLY THE BAXTER END. THE PATIENT BEGUN TAPING THE CONNECTOR SO THAT IT DOES NOT OPEN. THE NURSE STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT COMPLETED TREATMENT ON THE CYCLER. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE PATIENT WAS NOT SYMPTOMATIC AND WAS NOT TREATED WITH ANTIBIOTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9368444 ↗
• MalfunctionOct 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE SUPPLY BAG CONNECTOR AFTER ENDING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A SUPPLY BAG LINES ARE BLOCKED ALARM DURING DWELL 4 OF 4 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO RESET UP SUPPLIES AND TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PDRN STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE THE PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE SAMPLE USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7938134 ↗
• MalfunctionMay 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A FLUID LEAK WAS IDENTIFIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED THAT THE ADAPTER USED FOR THE SOLUTION BAG DISCONNECTED AND SOLUTION LEAKED DURING TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, OR INJURIES AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS GIVEN CEFTAZIDIME AND CEFAZOLIN INTRAPERITONEALLY PROPHYLACTICALLY. THE PDRN STATED THAT THE PATIENT WAS ABLE TO CONTINUE PD THERAPY WITH NO FURTHER ISSUES. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE REASSESSED AND UPDATED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531637 ↗
• InjuryApr 10, 2018Leak/Splash; Leak/Splash

  A PERITONEAL DIALYSIS NURSE REPORTED THE PATIENT EXPERIENCED A MALE CONNECTION SITE LEAK ON THEIR APD LUER-LOCK ADAPTOR. THE NURSE REPORTED THAT THE PATIENT HAD DRAINING ISSUES AND CLOUDY EFFLUENT. THE NURSE REPORTED THE PATIENT WAS TREATED FOR PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT IS RECOVERING AND CONTINUING WITH PERITONEAL DIALYSIS THERAPY. THE LIBERTY CYCLER SET WAS DISCARDED.

  Patient problems: Peritonitis

  MAUDE report 7412212 ↗
• InjuryOct 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FOLLOW UP CALL WITH A PERITONEAL DIALYSIS (PD) PATIENT¿S NURSE REVEALED THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017 TO (B)(6) 2017 DUE TO PERITONITIS WHILE COMPLETING MANUAL TREATMENT. THE PATIENT¿S EFFLUENT CULTURE SHOWED NO GROWTH AND THE WHITE BLOOD CELL WAS 26019 (UNITS UNKNOWN). THE PATIENT WAS TREATED WITH VANCOMYCIN AND CEFTAZIDIME (ROUTE AND DOSE UNKNOWN). ON (B)(6) 2017, A REPEAT CULTURE WAS PERFORMED AND THE WHITE BLOOD COUNT WAS 7304 (UNITS UNKNOWN). THE CAUSE OF THE PERITONITIS WAS SUSPECTED TO BE A BREACH IN ASEPTIC TECHNIQUE DUE TO A LEAK AT THE ADAPTER CONNECTION. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS EVENT.

  Patient problems: Peritonitis

  MAUDE report 6909113 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173593, K250404, K822550. One submission often covers many models, so check the product and lot details in each record.

• Z-1323-2024 · Jan 23, 2024 · Open, Classified
  stay-safe /Safe Lock Catheter Ext. 12 in
• Z-1325-2024 · Jan 23, 2024 · Open, Classified
  stay-safe /Luer Lock Catheter Ext. 12 in
• Z-1326-2024 · Jan 23, 2024 · Open, Classified
  stay-safe /Luer Lock Catheter Ext. 18 in
• Z-1327-2024 · Jan 23, 2024 · Open, Classified
  stay-safe /Luer Catheter Ext. 6 in
• Z-0017-05 · Sep 20, 2004 · Terminated
  Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034