Fresenius Medical Care Holdings, Inc. Recall 93396
Description: Stay Safe Cap
Fresenius Medical Care Holdings, Inc. Recall 93396 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0507-2024 |
Event ID | 93396 |
Event Description | Stay Safe Cap |
Product Type | Devices |
Distribution | US Nationwide distribution. |
Quantity | 18,236,160 eaches |
Recall Reason | Updating the labeling to include additional warnings and contraindications for potential side effects. |
Device Classification | 20231213 |
Device Code Info | Model No. 050-95012; UDI-DI: 00840861100835; All Lots. |
Center Classification Date | 20231207 |
Recall Initiation Date | 20231010 |
Recalling Firm | Fresenius Medical Care Holdings, Inc. |
Initial Notification | Letter |
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