CellEra recalls 20500 Vitale Silver calcium Alginate Dressing Ropes with incorrect instructions. Affected products may have unsafe use guidance; correct instructions will be sent.
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 some Silver calcium Alginate Dressing Ropes because they came with incorrect instructions that could lead to unsafe use. This is a correction to prevent potential misuse of the product.
The recalled products included instructions that went beyond what was approved by the FDA. This could lead to improper use, but the hazard is not immediate or severe.
People who own or use the recalled dressing ropes, especially those in medical settings or home care. Those using the product without the correct instructions may be at slightly higher risk.
Check for the lot numbers 200999, 00856276008642, or 00856276008635 on the packaging. The product is sold in boxes of 5 dressing ropes.
Look for the lot numbers 200999, 00856276008642, or 00856276008635 on the packaging.
The recalled products had instructions that went beyond the FDA-approved version, which could lead to unsafe use.
Check for the lot numbers 200999, 00856276008642, or 00856276008635 on the packaging.
The company is replacing the incorrect instructions with the correct version, so no action is needed beyond checking the lot numbers.
We’ve drafted a message you can send CellEra to request your refund or repair — edit it as you like.
Subject: Recall Z-0801-2022 — CellEra CellEra Hello, I own a CellEra that is covered by recall Z-0801-2022 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.
