Home / Recalls / Medical Devices
CooperSurgical, Inc. recalls The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade p
Recalled June 2, 2021 · FDA recall Z-1686-2021 · CooperSurgical
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. · FDA Class II
Units
6 boxes or 12 units
Sold at
Domestic: UT, OH, DE
Description
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.
Product
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
Manufacturer(s)
CooperSurgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →