FDA-Device2015-05-27Class II
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
CooperSurgical, Inc.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
430 units
Manufactured in
75 Corporate Dr, N/A, Trumbull, CT, United States
Products
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1630-2015Don't want to check this manually?
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