FDA Recall
Terminated
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
Recall: Z-0802-2022
·
Initiated December 15, 2021
Recall
- Recall Number
- Z-0802-2022
- Event Number
- 89453
- Firm
- CellEra LLC
- FEI Number
- 3007594734
- Product Code
- FRO
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- December 15, 2021
- Posted
- March 16, 2022
- Terminated
- October 16, 2023
- Address
- 1045 Reed Dr, Ste C, Monroe, OH, 45050-1717
Description
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
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.
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.
Distribution
US Nationwide distribution.
Quantity
9200 ea