Recall Z-0803-2022 ยท FRO Dressing, Wound, Drug
CellEra LLC
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
| Date | Mar 16, 2022 (initiated Dec 15, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | On December 15, 2021, the firm notified customers who had received product from CellEra within the past six months. The firm requested these customers hold any merchandise on hand pending receipt of replacement IFU's. The firm communicated with those companies to determine how many new IFU's they require for their inventory and for their customers. |
| Quantity | 4400 ea |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.