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Terminated

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

FDA Recall Z-1630-2015 · Posted 2015-05-19

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeNLM
Date Initiated2015-03-20
Date Terminated2015-07-29
Product Quantity430 units

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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