BVI CustomEyes Procedure Packs containing Sol-M syringes recalled
Beaver Visitec International recalls BVI CustomEyes Procedure Packs nationwide due to the inclusion of syringes manufactured by Sol-Millennium Medical that are subject to a voluntary manufacturer recall.
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 voluntary precautionary recall of a Class II medical device with no reported illnesses, injuries, or deaths mentioned in the source. Per the severity rubric, voluntary recalls without reported harm typically receive a Moderate rating.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001878, Lot 6074027) containing low dead space luer lock and luer slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The syringes in these procedure packs are subject to a voluntary recall initiated by the syringe manufacturer.
The recalled procedure packs were distributed nationwide throughout the United States. These are used as part of eye surgery procedures.
Users of BVI CustomEyes Procedure Packs should check their inventory to identify units containing the affected syringes and review communications from Beaver Visitec International regarding appropriate handling of the recalled product.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001878;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 6
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: 58001878
- UDI-DI: 30886158033678
- Lot/Batch Number: 6074027
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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