The Everest Bipolar Cutting Forceps are intended to be recall: Sterility Concern
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the…
Why was The Everest Bipolar Cutting Forceps are intended to be recalled?
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
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: 00821925035898 Batch Number: FR145210 FR150478 FR163740 FR165213 FR177466 FR179534 FR179557 FR188129 FR200177 FR215047 FR220528 FR220979 FR224466 FR234887 FR248322 FR253501 FR255664 FR263141 FR269277 FR276180 FR287091 FR303624 FR305537 FR316877 FR378738 FR388883 PW308633 PW308686 PW308722 PW308723
- Product
- The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 4364 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, DE, AU, SG, KR.
- Recall date
- August 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)