Recall Z-0803-2022
CellEra LLC · initiated December 15, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Codes / lots: Lot 206999 GTIN 10856276008663, 00856276008666, 00856276008659
Reason for recall
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-0803-2022
- Initiated
- December 15, 2021
- Posted by FDA
- March 16, 2022
- Terminated
- October 16, 2023
- Product code
- FRO – Dressing, Wound, Drug
- Quantity
- 4400 ea
- Distribution
- US Nationwide distribution.
- Recalling firm
- CellEra LLC, Monroe, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0801-2022 Class III | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | 12/15/2021Terminated |
| Z-0802-2022 Class III | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | 12/15/2021Terminated |
| Z-0804-2022 Class III | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | 12/15/2021Terminated |
| Z-0805-2022 Class III | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/boxFirm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the… | 12/15/2021Terminated |