Covidien recalls 5mm Endo Clinch II Auto Suture Graspers with inconsistent sterilization method. This may affect surgical safety. Contact for remedy details.
Sterilization method used was not consistent with the labeling and the approved sterilization method
Covidien is recalling its Endo Clinch II Auto Suture Graspers (5mm model) due to inconsistent sterilization methods that don't match the labeled process. This could lead to improper sterilization and potential infection risks during medical procedures.
The sterilization method used for these devices does not match what's stated on the label or approved by regulators. This inconsistency could mean the devices aren't properly sterilized, potentially leading to infections during surgery.
Surgical professionals and hospitals using the recalled graspers. Those most at risk are medical staff handling the devices during procedures.
Check for the model name 'Endo Clinch II Auto Suture Grasper 5mm' and lot numbers: P8D1333PRX through P8F1545PRX. These devices were sold with the reference number 174317.
Look for lot numbers on the device: P8D1333PRX through P8F1545PRX.
The sterilization method used for these devices does not match the labeling or approved sterilization method, which could lead to improper sterilization and infection risks.
Check the lot number on the device. If it matches the listed numbers (P8D1333PRX through P8F1545PRX), contact Covidien for further instructions.
The recall is due to potential infection risks from improper sterilization, not direct injury risks like cuts or fires. This is a low-risk issue.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1211-2019 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1211-2019 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.
