Fresenius Medical Care recalls Stay-Safe Luer Catheter Ext 6 in due to potential leachables in tubing. Affected units have specific model and lot numbers.
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Fresenius Medical Care is recalling their Stay-Safe Luer Catheter Ext 6 in because the tubing may contain harmful substances. This could pose a risk to patients using medical devices.
The tubing in the catheter may leach harmful substances called NDL PCBAs. This could potentially affect patient safety during medical procedures.
Healthcare professionals and patients using the Stay-Safe Luer Catheter Ext 6 in for medical procedures are likely affected. Those with the specific model and lot numbers are at risk.
Check for the model number 050-95013 and lot numbers 00840861100804 (bag) or 10840861100801 (case). All units of this product are affected.
Identify the model number 050-95013 and lot numbers 00840861100804 (bag) or 10840861100801 (case).
The recall states the tubing may leach harmful substances, so it is not safe to use without recalling it.
Check for model number 050-95013 and lot numbers 00840861100804 (bag) or 10840861100801 (case).
The recall does not specify a remedy, so contact the manufacturer for guidance.
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-1327-2024 — Fresen: Medical Care Fresen: Medical Care Hello, I own a Fresen: Medical Care that is covered by recall Z-1327-2024 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.
