Fresenius Medical Care Holdings, Inc. Recall 94084
Description: stay-safe /Luer Lock Adapter 4 in
Fresenius Medical Care Holdings, Inc. Recall 94084 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1324-2024 |
| Event ID | 94084 |
| Event Description | stay-safe /Luer Lock Adapter 4 in |
| Product Type | Devices |
| Distribution | Domestic: Nationwide Distribution. |
| Quantity | 828,954 eaches |
| Recall Reason | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. |
| Device Classification | 20240403 |
| Device Code Info | Model Number: 050-95003; UDI/DI (Bag): 00840861100774; UDI/DI (Case): 10840861100771; All lots. |
| Center Classification Date | 20240326 |
| Recall Initiation Date | 20240123 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
| Similar To |