CellEra recalls 4x4 Silver calcium Alginate Dressings due to incorrect instructions in some batches. Affected items may have unsafe usage guidance.
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 4x4 Silver calcium Alginate Dressings because some batches included incorrect instructions for use. This could lead to improper application if users follow outdated guidance.
The recalled dressings contain instructions beyond what was approved by the FDA. If users follow these incorrect instructions, they might apply the dressing improperly, leading to ineffective wound care.
Patients using these dressings for wound care are most at risk if they follow outdated instructions. Healthcare providers who use the product may also be affected.
Check for lot numbers 206999, 00856276008663, 00856276008666, or 00856276008659 on the packaging. The product is sold as 4x4 Silver calcium Alginate Dressings in 10-pack boxes.
Review the product's Instructions for Use to confirm they match the correct version approved by the FDA.
The dressings are safe if users follow the correct Instructions for Use. The recall addresses outdated instructions in some batches.
Look for lot numbers 206999, 00856276008663, 00856276008666, or 00856276008659 on the packaging.
Check the Instructions for Use to ensure they are the correct version approved by the FDA. No immediate action is needed if the instructions are correct.
We’ve drafted a message you can send CellEra to request your refund or repair — edit it as you like.
Subject: Recall Z-0803-2022 — CellEra CellEra Hello, I own a CellEra that is covered by recall Z-0803-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
