FDA Devices Low Class III Terminated

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

Reported: March 23, 2022 Initiated: December 15, 2021 #Z-0801-2022

Product Description

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: 30,000 ea
Distribution: US Nationwide distribution.
Location: Monroe, OH

Frequently Asked Questions

What product was recalled? ▼

20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box. Recalled by CellEra LLC. Units affected: 30,000 ea.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 23, 2022. Severity: Low. Recall number: Z-0801-2022.

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