FDA Enforcement
Class I
Ongoing
stay-safe /Luer Lock Adapter 4 in
Recall: Z-1324-2024
·
Reported April 3, 2024
Enforcement
- Recall Number
- Z-1324-2024
- Event ID
- 94084
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 3, 2024
- Initiation Date
- January 23, 2024
- Classification Date
- March 26, 2024
- Address
- 920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States
Description
stay-safe /Luer Lock Adapter 4 in
Reason
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Code Info
Model Number: 050-95003; UDI/DI (Bag): 00840861100774; UDI/DI (Case): 10840861100771; All lots.
Distribution
Domestic: Nationwide Distribution.
Quantity
828,954 eaches