BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by their manufacturer. Approximately 332 units were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Class II medical device recall involving syringes. The recall is voluntary with no reported illnesses, injuries, or deaths, and no specific hazard is identified in the notice. Per the FDA severity rubric, voluntary precautionary recalls are typically classified as Moderate.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing 1ml syringes with Luer Lock and Luer Slip tips manufactured by Sol-Millennium Medical (Sol-M), Inc., Part Number 58001944, Lot 6070908. Approximately 332 units were distributed nationwide in the United States.
The recall is voluntary and is initiated because these syringes are subject to a recall by their manufacturer, Sol-Millennium Medical, Inc. The specific defect prompting the manufacturer's recall is not detailed in this announcement.
Consumers and healthcare providers should contact Beaver Visitec International for instructions regarding these recalled procedure packs.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001944;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 332
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: 58001944
- UDI-DI: 30886158033630
- Lot/Batch Number: 6070908
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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