Device product
20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Z-0804-2022
Product summary
- Firm
- CellEra LLC
- Event
- Event 89453
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17850 ea
- Official record key
device-enforcement:Z-0804-2022
Official wording
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.
Code information: Lot 212299 GTIN 10856276008700, 00865276008703, 00856276008697
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.