BVI CustomEyes Procedure Packs containing syringes recalled nationwide
BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall affecting 73 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: The source indicates a voluntary, precautionary recall of medical device syringes without reported illnesses or injuries. FDA Class II classification applies, but without documented harm or clear hazard description, this meets the rubric criteria for a moderate-severity, precautionary recall.
Plain-English summary
BVI CustomEyes Procedure Packs containing low dead space and Luer slip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are being voluntarily recalled. The affected product has Part Number 584712 and Lot/Batch Number 6070547.
Approximately 73 units of the affected procedure packs were distributed across the United States.
The recalled product can be identified by UDI-DI 30886158142455.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584712;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 73
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: 584712
- UDI-DI: 30886158142455
- Lot/Batch Number: 6070547
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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