Reported May 27, 2015 · Terminated
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 75 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
- Lot codes and dates
- Lot 174422
- Amount recalled
- 430 units
Where it was sold
- Nationwide
Why it was recalled
The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes.
This product could cause temporary or reversible health problems — stop using it.
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