Covidien recalls Dermacea Gauze Fluff Rolls with potential sterility breach due to seal defects. Affected lots 18D180662, 18E070362, 18E222362, 18F072362. Stop using if seal appears pinched.
Potential for product sterility breach due to a compromised or pinched seal defect
Covidien is recalling Dermacea Gauze Fluff Rolls that may have a seal defect causing sterility breaches. This could lead to infections if used improperly. The recall affects specific lot numbers sold between 2018 and 2020.
The gauze rolls may have a pinched or compromised seal that allows bacteria to enter. This could breach the product's sterility, increasing infection risk during wound dressing.
People who own Dermacea Gauze Fluff Rolls with lot numbers 18D180662, 18E070362, 18E222362, or 18F072362 are affected. Those using the product for wound care are most at risk if the seal is compromised.
Check the lot number on the packaging. Affected lots are 18D180662, 18E070362, 18E222362, and 18F072362. The product is sold as both primary and secondary dressings for wounds.
Look for the lot number on the packaging to determine if it's affected (18D180662, 18E070362, 18E222362, or 18F072362).
If the seal is pinched or compromised, do not use the product as it may cause sterility breaches.
Affected lot numbers are 18D180662, 18E070362, 18E222362, and 18F072362.
Check if the seal appears pinched or compromised. If so, stop using it immediately.
The recall does not specify a remedy. Affected products should be stopped if the seal is compromised.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-0017-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-0017-2019 from Covidien. 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.
