Z-1630-2015Class II

Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic...

Name: Z-1630-2015 Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic...
Creator: CooperSurgical, Inc.
Published: 2015-03-20
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-03-20 / Terminated / root cause: design

FDA source

CooperSurgical, Inc. began a recall of Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery on 2015-03-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1630-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-20
Posted: 2015-05-19
Terminated: 2015-07-29
Recalling firm: CooperSurgical, Inc.
Product: Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
Product code: NLM Laparoscope, General & Plastic Surgery, Reprocessed
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.
Root cause tag: design
FDA 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 in commerce: 430 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot 174422

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1630-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1630-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-19

Product code NLM

K133414Class IIReprocessed Closure SystemSterilmed, Inc. / cleared 2014-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)