Catheter Extension Recalled by Fresenius Due to Chemical Leachables
Fresenius is recalling 479,978 stay-safe Luer Lock Catheter Extensions due to chemical leachables in the tubing. Healthcare providers should contact the manufacturer for replacement information.
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: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. Since no illnesses, injuries, or deaths are reported in the source text, the severity is Severe (4) rather than Critical (5).
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the stay-safe /Luer Lock Catheter Extension (18 inches). A total of 479,978 units are affected, including all lots of Model Number 050-95005, distributed nationwide.
The recall was initiated because the device's peroxide cross-linked tubing contains leachables identified as NDL PCBAs. This FDA Class I recall reflects the serious nature of this materials defect.
Healthcare facilities and patients using this specific catheter extension model should be informed of this recall. All lots of the product are included.
For information regarding replacement products or next steps, patients and healthcare providers should contact Fresenius Medical Care Holdings, Inc. Further guidance on managing care during this recall is available from the manufacturer.
The recalled product
- Product
- stay-safe /Luer Lock Catheter Ext. 18 in
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 479,978
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: 050-95005
- UDI/DI (Bag): 00840861100798
- UDI/DI (Case): 10840861100795
- 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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