Covidien recalls EMEA-distributed surgical kits with potential infection risk due to sterile packaging compromise. Affected kits include specific model codes and lots.
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Covidien is recalling surgical kits sold in Europe, the Middle East, and Africa that may have compromised sterile packaging, increasing infection risk during use. This recall affects medical professionals and surgical teams using these kits.
The sterile packaging might be damaged, allowing contaminants to enter the kits. Using these kits without proper sterility could lead to infections during surgical procedures.
Medical professionals and surgical teams in Europe, the Middle East, and Africa who use the recalled kits are most at risk. Patients receiving procedures with these kits could face infection.
Check for model codes like BREASTKIT01, LAR28PLN, or MGBGLOCX1 on the kit packaging. The kits were distributed in Europe, the Middle East, and Africa between the listed production lots.
Look for specific model codes and production lots listed in the recall notice to confirm if your kit is affected.
No, these kits were distributed only in Europe, the Middle East, and Africa. They are not available in the U.S.
The recall states that compromised sterile packaging could increase the risk of infection during surgical procedures.
Check the model codes and production lots listed in the recall notice, which include specific codes like BREASTKIT01 and lots such as 0218917589.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1447-2020 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1447-2020 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.