CellEra recalls 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box due to incorrect Instructions for Use inserted in some products. Correct version will be mailed.
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.
CellEra is recalling certain Silver calcium Alginate Dressings because they contain incorrect instructions for use. This could lead to improper application if users follow the wrong instructions.
The dressings include an incorrect version of the Instructions for Use that goes beyond what was approved by the FDA. This could cause users to apply the product incorrectly, potentially leading to improper wound care.
Patients using these dressings for wound care are affected. Healthcare providers who use the product are most at risk of applying it incorrectly.
Check for the product name 'Vitale Silver calcium Alginate Dressings 2x2, 10/box' with lot numbers 229999 and GTINs 10856276008762, 00856276008765, 00856276008758.
Look for the lot number 229999 and GTINs listed in the recall notice to confirm if your product is affected.
Reach out to CellEra LLC for assistance with the recall process or to get the corrected instructions.
The recall is due to an incorrect version of the Instructions for Use being inserted in some products, which goes beyond the cleared 510(k) by the FDA.
Check for the lot number 229999 and GTINs 10856276008762, 00856276008765, or 00856276008758 on the packaging.
Contact CellEra LLC for instructions on how to get the corrected instructions or return the product.
We’ve drafted a message you can send CellEra to request your refund or repair — edit it as you like.
Subject: Recall Z-0802-2022 — CellEra CellEra Hello, I own a CellEra that is covered by recall Z-0802-2022 from CellEra. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
