Recall Z-0805-2022— CellEra LLC
Class III · Terminated
Class III FDA medical device recall by CellEra LLC, initiated 2021-12-15, terminated 2023-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/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..
- Recalling firm
- CellEra LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-12-15
- Terminated
- 2023-10-16
- Firm location
- Monroe, OH, United States
Product description
20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.