FDA recalls BVI CustomEyes ophthalmic procedure packs nationwide
Beaver Visitec International initiated a voluntary recall of BVI CustomEyes Procedure Packs containing surgical syringes (Part Number 584550, Lot 6048601) distributed nationwide. The Class II recall was initiated on July 26, 2024.
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 medical device recall initiated voluntarily by the manufacturer with no reported adverse events, injuries, or hospitalizations in the source material. Voluntary precautionary recalls without reported harm are classified as Moderate per the severity rubric.
Plain-English summary
Beaver Visitec International, Inc., has recalled BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes. The affected product has Part Number 584550 and Lot Number 6048601. A total of 4 units were distributed nationwide in the United States.
This is a voluntary, firm-initiated Class II recall initiated on July 26, 2024. The FDA Class II classification indicates that the product could potentially cause serious adverse health consequences.
Healthcare facilities and individuals in possession of the affected product should discontinue use immediately. Contact Beaver Visitec International, Inc., or the FDA for additional information about the recall or to report any adverse events associated with this product.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- device-defect
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 (3)
- Part Number: 584550
- UDI-DI: 30886158140758
- Lot/Batch Number: 6048601
Distribution
Distributed nationwide across the United States.
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