CellEra LLC Recall 89453
Description: 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
CellEra LLC Recall 89453 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0801-2022 |
| Event ID | 89453 |
| Event Description | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 30,000 ea |
| Recall Reason | Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU. |
| Device Classification | 20220323 |
| Device Code Info | Lot 200999 GTIN 10856276008649, 00856276008642, 00856276008635 |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20211215 |
| Recalling Firm | CellEra LLC |
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