stay.safe® 050-95013Recalls & reported problems
Fresenius Medical Care Holdings, Inc. · stay.safe® Catheter Extension Set with Luer-Lock, 6 inch · Class 2
All models of stay.safe (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840861100804), received between Sep 14, 2017 and Mar 18, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
- Jan 23, 2024Class IOpen, Classified
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Z-1327-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK DURING THEIR PD TREATMENT. THE PATIENT REPORTED RECEIVING A PATIENT LINE IS BLOCKED (SOFT ALARM) DURING DRAIN 5 OF 6 OF TREATMENT. THE PATIENT REPORTED THAT THE PATIENT LINE EXTENSION CAME OFF AND THEY PUT IT BACK TOGETHER, HOWEVER THEIR BED GOT WET. THE TECHNICAL SUPPORT REPRESENTATIVE ASSISTED THE PATIENT IS CANCELLING THEIR TREATMENT AND ADVISED TO FOLLOW UP WITH THEIR PERITONEAL DIALYSIS NURSE (PDRN). UPON FOLLOW UP, THE PDRN STATED THAT THE PATIENT BECAME DISCONNECTED FROM THE CATHETER EXTENSION SET TO THE CATHETER, RESULTING IN THE LEAK REPORTED. THE PATIENT CAME TO THE CLINIC AND HAD THEIR CATHETER EXTENSION SET, A FRESENIUS PRODUCT, REPLACED. THE LOT NUMBER OF THE CATHETER EXTENSION SET THAT WAS USED WAS UNKNOWN. THE PATIENT RETURNED TO THE CLINIC AFTER A WEEK FOR A PERITONITIS PROTOCOL AFTER THE DISCONNECTION, WHICH IS AN EFFLUENT CULTURE, WHICH CAME BACK NEGATIVE. THE PATIENT WAS PRESCRIBED PROPHYLACTIC ANTIBIOTICS (TYPE, DOSE, ROUTE, DURATION NOT PROVIDED) AFTER THE EVENT PER CLINIC PROCEDURE. DESPITE THE PROPHYLACTIC ANTIBIOTICS, THAT THERE WERE NO SYMPTOMS, ADVERSE EVENTS, OR INJURIES REQUI
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8429218 ↗MalfunctionSep 14, 2017Fluid/Blood Leak; Fluid/Blood Leak
A PERITONEAL DIALYSIS PATIENT REPORTED THAT THE CYCLER DISPLAYED THE PATIENT LINE IS BLOCKED MESSAGE. THE PATIENT CONFIRMED THAT ALL CLAMPS WERE OPEN AND THERE WAS NO KINKS, AIR BUBBLES OR FIBRIN IN THE TUBING. THE PATIENT NOTICED THAT THE BLUE PIN OF THE CONNECTER HAD BEEN PUSHED IN. THE PATIENT SWAPPED OUT THE CONNECTOR FOR A NEW ONE. ONCE THE PATIENT PRESSED OK, IT WAS NOTED THAT FLUID WAS LEAKING FROM THE CONNECTOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6866776 ↗
Other SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE devices
- MiniCap 5C4482Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE3 recalls5 deaths2,961 reports
- MiniCap 5C4483Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE4 recalls433 reports
- Safe-Lock® 050-95018Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE2 recalls509 reports
- 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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