Product Wiki · Recalls · U.S. FDA — Device Enforcement

20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box — recall Z-0804-2022

U.S. FDA — Device Enforcement · United States · 2021-12-15 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0804-2022
Date of alert
2021-12-15
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
CellEra LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution.
Barcode (EAN/GTIN)
10856276008700
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.