BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. The recall affects 876 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: This is a voluntary, precautionary recall with no reported illnesses or injuries. The specific defect is not disclosed in the source. FDA Class II recalls without reported hospitalization or injury reports typically merit a Moderate severity score.
Plain-English summary
Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001373) that contain low dead space and luer slip 1ml syringes manufactured by Sol-Millennium Medical, Inc.
The recall involves 876 units that were distributed nationwide. The affected product can be identified by lot numbers 6058442 and 6064858. The product's UDI-DI is 30886158024386.
This is a voluntary recall of the syringes manufactured by Sol-Millennium Medical, Inc., which are present in some BVI CustomEyes Procedure Packs.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001373;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 876
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 (4)
- Part Number: 58001373
- UDI-DI: 30886158024386
- Lot/Batch Number: 6058442
- 6064858
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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