BVI Visitec Irrigation Handle lacks manufacturing and expiration dates
Beaver Visitec International is recalling 3,000 BVI Visitec Irrigation Handles because the pack and pouch labels are missing manufacturing and expiration date information.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a minor labeling defect with no reported illnesses or injuries. Missing manufacturing and expiration dates constitute a labeling error rather than a physical product hazard.
Plain-English summary
The BVI Visitec Irrigation Handle (Catalog Number 581012) manufactured by Beaver Visitec International, Inc. is intended to be fitted with a cannula for irrigation of the eye during surgical procedures. The company is recalling 3,000 units due to a labeling defect.
The pack and pouch labels on the affected units are missing the manufacturing and expiration dates. The recalled units are identified by Lot Numbers 21C0925 and 21C0926, with UDI Number 50886158002227.
The devices were distributed worldwide to the United States, Australia, Canada, Germany, Switzerland, and the United Kingdom.
The recalled product
- Product
- BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- missing-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926
Distribution
Distributed nationwide across the United States.
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