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

Recall date

March 20, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1630-2015

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

US Nationwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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