20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box recallZ-0805-2022 · CellEra LLC · initiated Dec 15, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CellEra LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-0805-2022
- Status
- Terminated
- Initiated by the company
- Dec 15, 2021
- Posted by the FDA
- Mar 16, 2022
- Recalling firm
- CellEra LLC
- Quantity
- 11770 ea
- Product code
- FRO
- Distribution
- US Nationwide distribution.
Product description
20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
Code information (models, lots, serial numbers)
Lot 212299, 200999 GTIN 10850005565250, 00850005565253, 00850005565246
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vitale 20548Cellera LLC · Dressing, Wound, Drug1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 89453).
- Z-0801-2022 · Terminated20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
- Z-0802-2022 · Terminated20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
- Z-0803-2022 · Terminated20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
- Z-0804-2022 · Terminated20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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