CellEra recalls 20548 Vitale Silver calcium alginate dressings with incorrect instructions that could lead to improper use. Affected lots from 200999 to 200999 sold in 2009-2010.
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 Vitale Silver calcium alginate dressings that had incorrect instructions for use. This could lead to improper application and potential misuse of the product.
The dressings came with instructions that were not approved by the FDA. This could lead to improper use if the instructions are followed incorrectly.
Healthcare professionals and patients using the Vitale Silver dressings may be affected. Those who have the specific lot numbers are most at risk.
Check for lot numbers 212299, 200999 on the packaging. The product is a 4x8 size, 5 per box with GTINs starting with 10850005565250.
Verify the Instructions for Use (IFU) matches the correct version provided by CellEra.
CellEra discovered that an incorrect version of the Instructions for Use was included in the affected products, which could lead to improper use.
Check the lot number on the packaging; if it matches 212299 or 200999, contact CellEra for the correct instructions.
The recall is for incorrect instructions, not a physical hazard. There is no risk of serious injury from the product itself.
We’ve drafted a message you can send CellEra to request your refund or repair — edit it as you like.
Subject: Recall Z-0805-2022 — CellEra CellEra Hello, I own a CellEra that is covered by recall Z-0805-2022 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.
