BVI CustomEyes Procedure Packs Recalled for Defective Syringes
BVI is voluntarily recalling CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. A total of 97 units have been distributed nationwide.
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 a voluntary, precautionary Class II medical device recall with no reported injuries, illnesses, or deaths. The specific hazard is not detailed in the source material.
Plain-English summary
BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) are subject to a voluntary recall. The affected packs contain Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number 58001602.
A total of 97 procedure packs have been distributed to customers nationwide. The recalled products are identified by Part Number 58001602, UDI-DI 30886158032060, and Lot Number 6064637.
Customers in possession of the recalled procedure packs should discontinue use and contact BVI CustomEyes for replacement or instructions regarding their recalled units.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001602;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 97
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: 58001602
- UDI-DI: 30886158032060
- Lot/Batch Number: 6064637
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 159 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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