Covidien recalls specific surgical kits distributed overseas due to inconsistent sterilization method not matching labeling.
Sterilization method used was not consistent with the labeling and the approved sterilization method
Covidien is recalling certain surgical kits distributed overseas because the sterilization method used did not match the approved labeling. This could lead to improper sterilization of medical devices.
The sterilization process for these kits did not follow the labeled method, which could result in devices not being properly sterilized. This might lead to infections or other complications during surgery.
Surgical teams and hospitals that received these kits from the affected lots. Patients using these kits during procedures may be at risk if the sterilization was inconsistent.
Check for the specific kit names and lot numbers listed in the recall notice. The kits include items like KIT00529H, KIT00680, KIT00681, etc., with the listed lot numbers.
Identify if your kit has a lot number from the list provided in the recall notice.
The affected kits include specific models like KIT00529H, KIT00680, KIT00681, and others with the listed lot numbers.
Compare your kit's lot number to the list of affected lot numbers provided in the recall notice.
The recall notice does not specify a remedy, so no action is required beyond checking if your kit is affected.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1213-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1213-2019 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.
