FDAFDA · Food and drugs·Recall number Z-1326-2024
stay-safe /Luer Lock Catheter Ext. 18 in
Published April 3, 2024 · Recall initiated: January 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Domestic: Nationwide Distribution.
- Lot
- Model Number: 050-95005; UDI/DI (Bag): 00840861100798; UDI/DI (Case): 10840861100795; All lots.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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