Z-0804-2022 Class III Terminated
FDA device recall Z-0804-2022 was initiated by CellEra LLC on Dec 15, 2021 and is designated Class III. 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… The recall status is terminated (terminated Oct 16, 2023). Affected quantity: 17850 ea.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2022
- Initiation Date
- Dec 15, 2021
- Termination Date
- Oct 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17850 ea
Product Description
20545 Vitale Silver calcium Alginate Dressings 4x5, 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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot 212299 GTIN 10856276008700, 00865276008703, 00856276008697
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0804-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026