Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58000594, Lot 6073112) containing Sol-M manufactured 1 milliliter syringes due to a recall of those syringes by their manufacturer.
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 of a voluntary nature. No illnesses, injuries, or deaths have been reported. The specific hazard details are not provided in the source material.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1 milliliter syringes (Part Number 58000594). The affected lot is 6073112, with 76 units distributed nationwide in the United States.
Sol-Millennium Medical, Inc. (Sol-M), the manufacturer of these syringes, has issued a recall for the syringes contained in these procedure packs. The specific reason for Sol-M's recall is not detailed in this notice.
Customers and healthcare facilities that have received these procedure packs should discontinue use and contact Beaver Visitec International, Inc. for instructions regarding return or replacement of the affected packs.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000594;
- Manufacturer
- Beaver Visitec International, Inc.
- 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 (3)
- Part Number: 58000594
- UDI-DI: 30886158019948
- Lot/Batch Number: 6073112
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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