20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
FDA Recall #Z-0802-2022 — Class III — December 15, 2021
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.
Recalling Firm
CellEra LLC — Monroe, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
9200 ea
Distribution
US Nationwide distribution.
Code Information
Lot 229999 GTIN 10856276008762, 00856276008765, 00856276008758
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated