Z-1686-2021 Class II Ongoing
FDA device recall Z-1686-2021 was initiated by CooperSurgical, Inc. on April 23, 2021 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6 boxes or 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- April 23, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 boxes or 12 units
Product Description
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
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.
Distribution Pattern
Domestic: UT, OH, DE
Code Information
Lot 280819