Z-1630-2015 Class II Terminated
FDA device recall Z-1630-2015 was initiated by CooperSurgical, Inc. on Mar 20, 2015 and is designated Class II. 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… The recall status is terminated (terminated Jul 29, 2015). Affected quantity: 430 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2015
- Initiation Date
- Mar 20, 2015
- Termination Date
- Jul 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 430 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot 174422
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1630-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026