stay•safe® organizer 030-10807Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861102310), received between Jan 9, 2023 and Jan 9, 2023 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K173718); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS NURSE (PDRN) FOR A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED CUSTOMER SUPPORT AND REPORTED THE PATIENT HAS PERITONITIS AND HAS TO DO MANUALS. UPON FOLLOW UP, THE PDRN STATED THE PATIENT WAS EXPERIENCING ABDOMINAL PAIN. A S A RESULT, THE PATIENT WAS SEEN IN THE OUTPATIENT PD CLINIC ON (B)(6) 2022 AND HAD A PD CULTURE OBTAINED. PER THE PDRN, THE PD CULTURE GENERATED GROWTH OF YEAST. THE PATIENT IS BEING TREATED WITH INTRA-PERITONEAL (IP) VANCOMYCIN 2 GRAMS EVERY 5 DAYS AND ORAL FLUCONAZOLE 200 MG DAILY FOR 21 DAYS. THE PATIENT IS CONTINUING PD TREATMENT WITH THE SAME CYCLER WITHOUT ANY ISSUES. THE PDRN STATED THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR ANY ISSUES WITH FRESENIUS PRODUCTS IN RELATION TO THE EVENT. THE NURSE ATTRIBUTED THE PERITONITIS TO A BREACH IN INFECTION CONTROL AT HOME WHEREBY IT WAS STATED THE PATIENT DOES NOT REGULARLY BLEACH THE STAY SAFE ORGANIZER AS INSTRUCTED. ADDITIONAL DETAILS SURROUNDING THE PATIENT¿S HOSPITAL COURSE AND CONDITION WERE REQUESTED, HOWEVER, NOT PROVIDED.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 16126819 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173718. One submission often covers many models, so check the product and lot details in each record.

• Z-2151-2019 · May 29, 2019 · Terminated
  Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Lin