CooperSurgical recalls CloseSure System XL kits with incorrect component descriptions on Tyvek lid. Affected kits may have missing parts; contact for replacement.
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
CooperSurgical is recalling CloseSure System XL kits that have incorrect component descriptions on the Tyvek lid. This could mean users might not have the right parts for their procedure, which may lead to errors during use.
The Tyvek lid labels for individual kit trays have incorrect component descriptions. This could lead to users not having the right parts for their procedure, potentially causing errors during surgery.
Surgical teams using the CloseSure System XL kits with the specific reference number 733776 are affected. Those performing procedures requiring precise suture guidance are at higher risk.
Check for the reference number 733776 on the box. The kit includes one Carter-Thomason Suture Passer, one 5 mm Pilot Guide, and one 10/12 mm Pilot Guide.
Verify the kit includes one Carter-Thomason Suture Passer, one 5 mm Pilot Guide, and one 10/12 mm Pilot Guide.
The recall is for incorrect component descriptions on the Tyvek lid, which could lead to missing parts. However, the hazard is low risk as it does not cause immediate injury.
Check for the reference number 733776 on the box. The kit includes one Carter-Thomason Suture Passer, one 5 mm Pilot Guide, and one 10/12 mm Pilot Guide.
The recall does not specify a remedy, so contact CooperSurgical for guidance on next steps.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0985-2024 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0985-2024 from CooperSurgical. 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.
