Stay-safe Luer Lock catheter extension recalled for chemical leachables
Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires minimum score of 4 per the rubric. No reported illnesses, injuries, or deaths are documented to warrant elevation to score 5 (Critical).
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the stay-safe Luer Lock Catheter Extension (12 inches) due to chemical leachables in the tubing. The recall affects 663,221 units (Model Number 050-95004, all lots) distributed nationwide in the United States.
The catheter extension is manufactured using peroxide cross-linked tubing that contains chemical leachables identified as NDL PCBAs. These leachables are present in the tubing material resulting from the manufacturing process.
Healthcare professionals and facilities in possession of these catheter extensions are advised to contact Fresenius Medical Care with questions regarding the recall. Patients currently using the product should consult their healthcare provider.
The recalled product
- Product
- stay-safe /Luer Lock Catheter Ext. 12 in
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Catheter Tubing
- Hazard
- Affected units
- 663,221
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: 050-95004
- UDI/DI (Bag): 00840861100781
- UDI/DI (Case): 10840861100788
- All lots.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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