Berkeley VC-10 Vacuum Curettage System recall
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Why was Berkeley VC-10 Vacuum Curettage System recalled?
Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.
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?
UDI-DI: 00821925010475 All units are included.
- Product
- Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 4184 US; 191 OUS
- Distribution
- Domestic distribution nationwide. Foreign distribution to Canada and Japan.
- Recall date
- October 19, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)