DeRoyal recalls specific organ recovery packs with Medtronic non-absorbable sutures due to potential packaging gaps causing sterile barrier breaches. Affected lots have expiration dates through May 2023.
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
DeRoyal is recalling certain organ recovery packs that contain Medtronic non-absorbable sutures. The recall is because a manufacturing error might create a gap in the packaging, risking a sterile barrier breach during surgery.
The packaging error could create a gap or wrinkle in the breather seal of the sterile barrier. This might allow contamination to enter the surgical site, increasing the risk of infection.
Surgical teams and hospitals using the recalled organ recovery packs. Patients undergoing surgery with these packs are at risk of infection.
Check for the product name 'DeRoyal ORGAN RECOVERY PACK PGYBK' with lot numbers 57391129, 57755421, 57900931 (expiring May 1, 2023) or 57913767 (expiring May 1, 2023).
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your pack is affected.
Medtronic identified a manufacturing error in the packaging of non-absorbable sutures that could cause a gap in the sterile barrier.
A gap in the packaging might allow contamination to enter the surgical site, increasing infection risk during surgery.
Check for lot numbers 57391129, 57755421, 57900931 (expiring May 1, 2023) or 57913767 (expiring May 1, 2023) on the DeRoyal ORGAN RECOVERY PACK PGYBK.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0927-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0927-2023 from DeRoyal. 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.
