BVI CustomEyes Procedure Packs containing Sol-M syringes recalled
BVI CustomEyes Procedure Packs are being recalled because they contain Sol-Millennium Medical syringes that were voluntarily recalled by the manufacturer. The affected packs 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 issued on a voluntary basis with no reported illnesses, injuries, or deaths. The rubric explicitly identifies voluntary precautionary recalls as Moderate severity.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes are being recalled. The syringes, manufactured by Sol-Millennium Medical (Sol-M), were the subject of a voluntary recall by the manufacturer.
The affected procedure packs have been distributed nationwide in the United States. The recalled packs are identified by Part Number 58001374 and UDI-DI 30886158031926, with Lot/Batch Number 6062022. Approximately 306 units are impacted.
Consumers who have received these procedure packs should stop using them and contact Beaver Visitec International, Inc., the recalling firm, for instructions on return or replacement.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001374;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 306
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: 58001374
- UDI-DI: 30886158031926
- Lot/Batch Number: 6062022
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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