Syringes in BVI CustomEyes Procedure Packs Recalled Nationwide
Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The specific reason for the recall is not detailed in the FDA notice.
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 voluntary recall with no reported illnesses or injuries. The specific hazard is not articulated in the source material. Per the rubric, voluntary precautionary recalls are classified as Score 2 (Moderate).
Plain-English summary
Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs that contain low dead space syringes and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.
The recalled packs have Part Number 58001338 and Lot/Batch Number 6074329. A total of 64 units were distributed nationwide in the United States.
No specific defect or hazard is detailed in the recall notice. Consumers should stop using the affected packs and contact the recalling manufacturer for replacement or return.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 64
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: 58001338
- UDI-DI: 30886158023785
- Lot/Batch Number: 6074329
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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