BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M Inc. The recall affects 76 units 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: Voluntary recall with no reported adverse events or injuries specified in the source material. Per the severity rubric, voluntary recalls without reported illness or injury are classified as Moderate.
Plain-English summary
Beaver Visitec International, Inc. has initiated a voluntary recall of BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The procedure packs contain low dead space and luer slip tip syringes, with 76 units total affected by this recall.
The affected product is identified by part number 58001417, with UDI-DI 30886158024645. The affected lot numbers are 6071011 and 6072526. The product was distributed throughout the United States. The source material does not specify the reason for the recall or recommend any specific consumer actions.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Affected units
- 76
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 (4)
- Part Number: 58001417
- UDI-DI: 30886158024645
- Lot/Batch Number: 6071011
- 6072526
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.
See all 159 products in this recall →Related recalls
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FDA (Devices) · 2024-09-04
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