FDAClass IIMarch 20, 2024

BVI Visitec Irrigation Handle recall

BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012

Why was BVI Visitec Irrigation Handle recalled?

Pack and pouch label is missing the manufacturing and expiration date.

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 Number: 50886158002227 Lot Number: 21C0925 & 21C0926

Product
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Recalling firm
Beaver Visitec International, Inc.
Quantity
3,000 units (US and OUS)
Distribution
Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.
Recall date
March 20, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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