20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
Reported: March 23, 2022 Initiated: December 15, 2021 #Z-0802-2022
Product Description
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/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.
Details
- Recalling Firm
- CellEra LLC
- Units Affected
- 9200 ea
- Distribution
- US Nationwide distribution.
- Location
- Monroe, OH
Frequently Asked Questions
What product was recalled? ▼
20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box. Recalled by CellEra LLC. Units affected: 9200 ea.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2022. Severity: Low. Recall number: Z-0802-2022.
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