CooperSurgical Recalls Carter-Thomason II Port Closure System Due to Printing Defect
CooperSurgical is recalling 430 units of the Carter-Thomason II Port Closure System because pad printing on the suture guide may flake off.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The defect involves cosmetic pad printing flaking off, which is a minor manufacturing issue with no reported injuries or significant health risks.
Plain-English summary
CooperSurgical, Inc. is recalling 430 units of the Carter-Thomason II Port Closure System, Model CTI-1015P, which is used in endoscopic and laparoscopic surgery. The recall involves Lot 174422, which was distributed nationwide in the United States.
The recall was initiated because the pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured. This defect can result in the pad printing flaking off around the entry holes.
Healthcare facilities and consumers should stop using the affected product and contact CooperSurgical, Inc. for further instructions or a return.
The recalled product
- Product
- Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 430
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 (1)
- Lot 174422
Distribution
Distributed nationwide across the United States.
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