CellEra recalls 20545 Vitale Silver calcium Alg: 10/box dressings with incorrect instructions. Correct version of instructions will be mailed to affected customers.
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 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box due to incorrect Instructions for Use (IFU) included in some units. This could lead to improper use if customers follow outdated instructions.
The recalled dressings include an incorrect version of the Instructions for Use that goes beyond the cleared 510(k) regulations. This means users might follow instructions that are not approved for the product, potentially leading to improper wound care.
Patients using these dressings for wound care. Healthcare providers who use the product are most at risk of incorrect application.
Check for the lot numbers 212299, 00865276008703, or 00856276008697 on the packaging. The product is a 4x5 size, 10-pack box.
Look for the lot numbers 212299, 00865276008703, or 00856276008697 on the packaging.
Reach out to CellEra LLC to confirm if your product is affected and get instructions for the correct instructions.
The recall is due to an incorrect version of the Instructions for Use (IFU) that contains language beyond the cleared 510(k) regulations.
Check for the lot numbers 212299, 00865276008703, or 00856276008697 on the packaging of the 4x5, 10/box dressings.
Contact CellEra LLC to confirm if your product is affected and get instructions for the correct instructions.
We’ve drafted a message you can send CellEra to request your refund or repair — edit it as you like.
Subject: Recall Z-0804-2022 — CellEra CellEra Hello, I own a CellEra that is covered by recall Z-0804-2022 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.
