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.
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Fresenius Medical Care is recalling their Stay-Safe Luer Lock Adapter 4 in because the tubing may leach chemicals identified as NDL PCBAs. This could pose a risk to users, especially in medical applications where contamination might occur.
The tubing in the adapter uses peroxide cross-linking, which may release chemicals identified as NDL PCBAs. These chemicals could contaminate medical equipment or fluids, potentially causing harm if they come into contact with patients or medical staff.
Healthcare professionals and medical device users who have the Stay-Safe Luer Lock Adapter 4 in with model number 050-95003 are likely affected. Those using the device for medical purposes are at higher risk due to potential chemical exposure.
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.
Identify the model number 050-95003 and UDI/DI numbers to confirm if your adapter is affected.
The recall states that the tubing may leach chemicals, so it is not safe for medical use. Affected units should be discontinued.
Contact Fresenius Medical Care directly for instructions on how to handle the recalled product.
Yes, model number 050-95003 with UDI/DI (Bag) 00840861100774 or UDI/DI (Case) 10840861100771 are affected.
We’ve drafted a message you can send Fresen:ius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1324-2024 — Fresen:ius Medical Care Fresen:ius Medical Care Hello, I own a Fresen:ius Medical Care that is covered by recall Z-1324-2024 from Fresen:ius Medical Care. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.