CellEra LLC Recall 89453
Description: 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
CellEra LLC Recall 89453 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0804-2022 |
| Event ID | 89453 |
| Event Description | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 17850 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 212299 GTIN 10856276008700, 00865276008703, 00856276008697 |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20211215 |
| Recalling Firm | CellEra LLC |
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