Fresenius Medical Care recalls Safe Lock Catheter Extension 12 in due to potential leachables in tubing. Affected units have specific model and lot numbers. Consumers should contact for details.
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Fresenius Medical Care is recalling their Safe Lock Catheter Extension 12-inch product because the tubing may contain harmful substances. This recall affects all units with the specified model and lot numbers. If you own this product, you should contact the company for instructions.
The tubing in the catheter extension may contain leachables identified as NDL PCBAs. This could pose a risk if the substances enter the bloodstream during medical procedures. However, the exact health impact is not clearly described in the recall notice.
Healthcare professionals and patients using the Safe Lock Catheter Extension 12 in are likely affected. Those with the specific model number and lot numbers are at risk.
Check for the model number 050-95001 on the product. Look for the UDI/DI (Bag) number 00840861100767 or UDI/DI (Case) number 10840861100764. All units produced are affected.
Reach out to Fresenius Medical Care Holdings, Inc. for specific instructions on handling the recalled product.
The recall notice does not specify if the product is safe to use; it states that the tubing may contain leachables but does not detail the exact risk.
The recall notice does not provide specific action steps beyond contacting the manufacturer for details.
Check for the model number 050-95001 and UDI/DI numbers 00840861100767 (bag) or 10840861100764 (case). All units are affected.
We’ve drafted a message you can send Fresen: Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-1323-2024 — Fresen: Medical Care Fresen: Medical Care Hello, I own a Fresen: Medical Care that is covered by recall Z-1323-2024 from Fresen: 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.
