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Open, Classified

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

FDA Recall Z-1686-2021 · Posted None

Recalling FirmCooperSurgical, Inc.
Recall StatusOpen, Classified
Product CodeHEW
Date Initiated2021-04-23
Product Quantity6 boxes or 12 units

Reason for Recall

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.

Firm Action

On 04/30/2021, Cooper Surgical issued an Urgent Medical Device Removal notice to customers via letter notifying them Cooper Surgical is issuing this recall due to a labeling discrepancy with respect to the cup size, where a 3.5cm Ultem Cup was placed in the Product rather than a 3.0cm Ultem Cup as indicated by the Part Number on the packaging label.

Root Cause

Labeling design

Distribution Pattern

Domestic: UT, OH, DE

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954311KOH COLPOTOMIZER SYSTEMCooperSurgical, Inc. · 1996-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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