FDA Recalls stay-safe Luer Lock Adapter for Chemical Leachables
The FDA is recalling approximately 828,954 stay-safe Luer Lock Adapters due to chemical leachables identified in the peroxide cross-linked tubing. The nationwide recall affects all lots of Model Number 050-95003.
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 medical device recall with identified chemical leachables. No illnesses or injuries reported, but FDA Class I classification mandates a minimum severity score of 4 (Severe) per the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling approximately 828,954 stay-safe Luer Lock Adapter 4 in units under FDA Class I classification. The recall affects all lots of Model Number 050-95003 that have been distributed nationwide.
The adapters contain peroxide cross-linked tubing with identified chemical leachables designated as NDL PCBAs. This represents a potential health hazard related to the chemical composition of the tubing.
Recipients of these adapters should contact Fresenius Medical Care Holdings, Inc. for guidance on product disposition and any necessary corrective actions.
The recalled product
- Product
- stay-safe /Luer Lock Adapter 4 in
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 828,954
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: 050-95003
- UDI/DI (Bag): 00840861100774
- UDI/DI (Case): 10840861100771
- 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.
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