Catheter Extension Tubing Recalled Due to Identified Leachable Substances
Fresenius Medical Care is recalling 114,982 stay-safe Safe Lock Catheter Extensions due to peroxide cross-linked tubing leachables. Patients and healthcare providers are advised to discontinue use and contact the manufacturer for replacement.
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 mandates a minimum Severe rating. No deaths or serious injuries are reported in the source material, but the specific identification of leachables in a device that contacts the body justifies the serious classification.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling stay-safe Safe Lock Catheter Extensions (Model 050-95001) due to peroxide cross-linked tubing that contains identified leachables. These leachables are identified as NDL PCBAs.
The recall affects 114,982 units distributed nationwide to healthcare settings. All production lots of the affected model are included.
Patients and healthcare providers currently using this product should discontinue use immediately and contact Fresenius Medical Care Holdings, Inc. for replacement products or alternative solutions.
The recalled product
- Product
- stay-safe /Safe Lock Catheter Ext. 12 in
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 114,982
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: 050-95001
- UDI/DI (Bag): 00840861100767
- UDI/DI (Case): 10840861100764
- 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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