FDA-Device2021-06-02Class II
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
CooperSurgical, Inc.
Hazard
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
Sold states
Domestic: UT, OH, DE
Affected count
6 boxes or 12 units
Manufactured in
95 Corporate Dr, N/A, Trumbull, CT, United States
Products
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2021Don't want to check this manually?
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