FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
- Recall number
- Z-1630-2015
- Recalling firm
- CooperSurgical, Inc.
- Product
- Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
- Status
- Terminated
- Initiated
- 2015-03-20
- Posted
- 2015-05-19
- Terminated
- 2015-07-29
- 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.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 430 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot 174422
- 510(k) numbers
- ["K133414"]
- PMA numbers
- not on file
- Product code
- NLM
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28