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Recall Observatory FDA recall evidence

Device product

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

Z-1630-2015

March 20, 2015

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 70828
Status
Terminated
Classification
Class II
Quantity
430 units
Official record key
device-enforcement:Z-1630-2015

Official wording

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.

Code information: Lot 174422

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.