The Ultem Polymeric Resin Koh Cup is a non- sterile recall
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…
Why was The Ultem Polymeric Resin Koh Cup is a non- sterile recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 280819
- 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…
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 6 boxes or 12 units
- Distribution
- Domestic: UT, OH, DE
- Recall date
- June 2, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)