Recall Z-1630-2015— CooperSurgical, Inc.
Class II · Terminated
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2015-03-20, terminated 2015-07-29. It names one FDA 510(k) clearance: K133414. Product: Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.. Reason: 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..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-20
- Terminated
- 2015-07-29
- Firm location
- Trumbull, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.