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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- chemical-leachable
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.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03