UnratedMedical device recall · FDA · Published January 23, 2024
Fresenius Medical Care: Stay-Safe Luer Lock Adapter Recall Due to Chemical Leachables
Fresenius Medical Care recalls Stay-Safe Luer Lock Adapter 4 in due to peroxide cross-linked tubing leaching NDL PCBAs. Affected units include model 050-95003 with specific UDI/DI numbers. Consumers should contact the manufacturer for details.
“Fresenius Medical Care: Stay-Safe Luer Lock Adapter Recall Due to Chemical Leachables.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56271-fresenius-medical-care-stay-safe-luer-lock-adapter-recall-due. Based on FDA recall #Z-1324-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1324-2024%22&limit=1).
Fresenius Medical Care Holdings, Inc. voluntarily recalled stay-safe /Luer Lock Adapter 4 in units on Jan. 23, 2024, according to the FDA. The recall addresses leachables identified as NDL PCBAs in the peroxide cross-linked tubing.
How to tell if you have it
Brand: Fresenius Medical Care
Product: stay-safe /Luer Lock Adapter 4 in
Model Number: 050-95003
UDI/DI (Bag): 00840861100774
UDI/DI (Case): 10840861100771
Lots: All lots
The hazard
The peroxide cross-linked tubing contains leachables identified as NDL PCBAs.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since 2014-04-14. Other recent recalls of similar products include Fresenius Bicarby Dialysate Leaks Risk: Slip and Fall Hazard (2026-05-12), Fresenius 5008X Blood Tubing Set Recall: Risk of Online Port Errors (2026-05-11), and Fresenius Medical Care Bicarby Dialysate Recall: Incorrect Labeling Risk (2026-05-07).
How to tell if you have this one
Check for the model number 050-95003 on the adapter. The UDI/DI (Bag) number 00840861100774 or UDI/DI (Case) number 10840861100771 indicates the affected units. All lots of this product are included in the recall.
Brand
Fresen:ius Medical Care
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Domestic: Nationwide Distribution.
Recall number
Product, codes & lots
Quantity
Z-1323-2024
stay-safe /Safe Lock Catheter Ext. 12 in; Model Number: 050-95001; UDI/DI (Bag): 00840861100767; UDI/DI (Case): 10840861100764; All lots.
114,982 eaches
Z-1324-2024
stay-safe /Luer Lock Adapter 4 in; Model Number: 050-95003; UDI/DI (Bag): 00840861100774; UDI/DI (Case): 10840861100771; All lots.
828,954 eaches
Z-1325-2024
stay-safe /Luer Lock Catheter Ext. 12 in; Model Number: 050-95004; UDI/DI (Bag): 00840861100781; UDI/DI (Case): 10840861100788; All lots.
663,221 eaches
Z-1326-2024
stay-safe /Luer Lock Catheter Ext. 18 in; Model Number: 050-95005; UDI/DI (Bag): 00840861100798; UDI/DI (Case): 10840861100795; All lots.
479,978 eaches
Z-1327-2024
stay-safe /Luer Catheter Ext. 6 in; Model Number: 050-95013; UDI/DI (Bag): 00840861100804; UDI/DI (Case): 10840861100801; All lots.
105,700 eaches
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number 050-95003 and UDI/DI numbers to confirm if your adapter is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1324-2024 (January 23, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1324-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.