BVI CustomEyes Procedure Packs Recalled Nationwide for Syringe Defects
Beaver Visitec International has recalled 115 units of BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The voluntary recall addresses a manufacturing issue with the syringes included in the procedure packs.
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 recall of a Class II medical device with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (score 2).
Plain-English summary
Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001764, Lot 6072080) that contain Sol-M Luer Lock and Luer Slip 1ml syringes. These syringes are manufactured by Sol-Millennium Medical (Sol-M), Inc., which has initiated a voluntary recall of these syringe models.
The affected procedure packs have been distributed nationwide in the United States. A total of 115 units are included in this recall.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 115
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: 58001764
- UDI-DI: 30886158032435
- Lot/Batch Number: 6072080
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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