20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
Reported: March 23, 2022 Initiated: December 15, 2021 #Z-0803-2022
Product Description
20544 Vitale Silver calcium Alginate Dressings 4x4, 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
- 4400 ea
- Distribution
- US Nationwide distribution.
- Location
- Monroe, OH
Frequently Asked Questions
What product was recalled? ▼
20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box. Recalled by CellEra LLC. Units affected: 4400 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-0803-2022.
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