medical Class II Updated 2021-06-02

CooperSurgical, Inc. recalls The Ultem Polymeric Resin Koh Cup is a non- sterile, reusabl

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Affected States: UT, OH, DE
Lot/Code Info: Lot 280819
View official government recall

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