The Recall Desk
LowFDA (Devices)·Z-1630-2015·Announced 2015-05-27

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.

What this means for you

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.
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.