Carter-Thomason II Port Closure System recall
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
Why was Carter-Thomason II Port Closure System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 174422
- Product
- Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 430 units
- Distribution
- US Nationwide distribution.
- Recall date
- May 27, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)