Recall Z-1630-2015
CooperSurgical, Inc. · initiated March 20, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
Codes / lots: Lot 174422
Reason for recall
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.
FDA-determined cause: Component design/selection
Action taken
Consignees were notified of the recall by letter sent via FedEx dated March 20, 2015. The letter instructs consignees to do the following: discontinue use of the affected product, complete the attached acknowledgement and receipt form to return the product and schedule a replacement.
Details
- Recall number
- Z-1630-2015
- Initiated
- March 20, 2015
- Posted by FDA
- May 19, 2015
- Terminated
- July 29, 2015
- Product code
- NLM – Laparoscope, General & Plastic Surgery, Reprocessed
- Quantity
- 430 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- CooperSurgical, Inc., Trumbull, CT