Carter-Thomason CloseSure Surgical Kit Recall: Mislabeled Component Descriptions
CooperSurgical is recalling Carter-Thomason CloseSure System XL surgical kits due to incorrect component descriptions on packaging. The affected batch includes 127 boxes (381 total kits) with lot number 326728.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall where incorrect component descriptions on surgical kit packaging could lead to wrong component selection during procedures, creating a risk of harm. No illnesses or injuries have been reported, preventing a higher classification.
Plain-English summary
CooperSurgical, Inc. is recalling 127 boxes of the Carter-Thomason CloseSure System XL surgical kits, containing 381 total kits. The recall involves lot number 326728 (UDI-DI: 60888937027053).
The kits are being recalled because individual kit trays contain Tyvek lids with incorrect component descriptions in the "Contents" section.
The affected kits were distributed in the United States. No illnesses or injuries have been reported. Customers who have received these kits should contact CooperSurgical, Inc. for further guidance on return or replacement.
The recalled product
- Product
- Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 60888937027053
- lot# 326728.
Distribution
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