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Terminated

20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

FDA Recall Z-0803-2022 · Posted 2022-03-16

Recalling FirmCellEra LLC
Recall StatusTerminated
Product CodeFRO
Date Initiated2021-12-15
Date Terminated2023-10-16
Product Quantity4400 ea

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.

Firm Action

On December 15, 2021, the firm notified customers who had received product from CellEra within the past six months. The firm requested these customers hold any merchandise on hand pending receipt of replacement IFU's. The firm communicated with those companies to determine how many new IFU's they require for their inventory and for their customers.

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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