BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are being voluntarily recalled. The affected packs contain low dead space and luer slip tip 1ml syringes from Sol-Millennium Medical, Inc.
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: FDA Class II recall with voluntary, precautionary nature. No reported illnesses, injuries, or deaths in the source material. The source does not specify the particular defect associated with the recalled syringes.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes have been voluntarily recalled. The procedure packs contain low dead space and luer slip tip 1ml syringes (Part Number 58001809, Lot Number 6071159) manufactured by Sol-Millennium Medical (Sol-M), Inc.
The affected procedure packs were distributed nationwide in the United States.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001809;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 4
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: 58001809
- UDI-DI: 30886158032787
- Lot/Batch Number: 6071159
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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