Device 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
Z-1686-2021
Product summary
- Event
- Event 87849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 boxes or 12 units
- Official record key
device-enforcement:Z-1686-2021
Official wording
Reason: 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.
Code information: Lot 280819
Distribution pattern: Domestic: UT, OH, DE
Derived failure modes
-
Unknown
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.