Cycler Drain Bag Set 026-20226ARecalls & reported problems
Fresenius Medical Care Holdings, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861102037), received between Oct 14, 2024 and Oct 14, 2024 — classified as 1 injury.
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Apr 28, 2021Class IITerminated
Exposed to freezing temperatures due to refrigerated truck malfunctions
Z-2083-2021 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Peritonitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, IT WAS REPORTED THAT THIS FEMALE PERITONEAL DIALYSIS (PD) PATIENT HAD PERITONITIS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PATIENT HAD A REGULARLY SCHEDULED APPOINTMENT AT THE PD CLINIC FOR A LAB DRAW ON (B)(6) 2024. WHEN THE PATIENT ARRIVED, THE PATIENT¿S SPOUSE REPORTED THE PATIENT HAD THE DRY HEAVES FOR TWO DAYS. THE PDRN EXAMINED THE PATIENT AND NOTED FLUID IN THE ABDOMEN. THE SPOUSE STATED THAT THE PATIENT WAS EXPERIENCING DRAIN ALARMS FOR THREE DAYS AND WOULD JUST DISCONNECT FROM THE TREATMENT PRIOR TO COMPLETION. THE PDRN MANUALLY DRAINED THE PATIENT AND NOTED THE DRAIN BAG TO BE EXTREMELY CLOUDY WITH LOTS OF FIBRIN. A PD EFFLUENT CULTURE AND CELL COUNT WAS OBTAINED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE NEPHROLOGIST DECIDED NOT TO INITIATE ANTIBIOTIC THERAPY UNTIL THE LAB RESULTS CAME BACK DUE TO THE PATIENT¿S MANY DRUG ALLERGIES (UNSPECIFIED). ON (B)(6) 2024, THE PATIENT¿S WHITE BLOOD CELL (WBC) COUNT WAS >5,000. THE PATIENT WAS ADMINISTERED INTRAPERITONEAL (IP) CEFTAZIDIME AND VANCOMYCIN (DOSE, FREQUENCY, AND DURATION NOT PROVIDED) AT THE PD CLINIC UNDER NURSE SUPER
Patient problems: Peritonitis
MAUDE report 20439832 ↗
Other Set, Administration, For Peritoneal Dialysis, Disposable devices
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- MINICAP WITH POVIDONE-IODINE SOLUTION 5C4466PBaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall4 deaths347 reports
- MINICAP EXTENDED LIFE PD TRNS 5C4482ABaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE193 reports
- UltraSet CAPD Disposable Disconnect Y-Set L5C4366Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE100 reports
- stay.safe® 050-95012Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall48 reports
- stay.safe® 050-95004Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall43 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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