FDA Recalls Fresenius Catheter Extension Tubing Due to Chemical Leachables
Fresenius Medical Care is recalling 105,700 stay-safe /Luer Catheter Extension 6 in devices nationwide due to chemical leachables identified in the peroxide cross-linked tubing. FDA classified this as a Class I recall.
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 a minimum severity score of 4 per the rubric. Although no illnesses or adverse events are currently reported, the Class I designation reflects the agency's determination that chemical leachables in the tubing present a serious hazard potential.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling stay-safe /Luer Catheter Extension 6 in devices distributed nationwide. A total of 105,700 units are included in this recall, which affects all product lots (Model Number 050-95013).
The recall is due to the presence of chemical leachables identified in the peroxide cross-linked tubing used in these devices. The FDA has classified this as a Class I recall.
Users of these devices should discontinue use immediately and contact Fresenius Medical Care for instructions regarding replacement options and return procedures. Healthcare providers and facilities with these devices in stock should verify they are not being used and take appropriate action.
The recalled product
- Product
- stay-safe /Luer Catheter Ext. 6 in
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 105,700
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: 050-95013
- UDI/DI (Bag): 00840861100804
- UDI/DI (Case): 10840861100801
- 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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