BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled
BVI CustomEyes Procedure Packs containing syringes made by Sol-Millennium Medical (Sol-M) are being voluntarily recalled. These affected syringes are low dead space and luer slip tip 1ml models.
What this means for you
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: FDA Class II recall with no reported injuries or hospitalizations. The source characterizes this as a voluntary precautionary recall, matching the rubric definition for Moderate severity.
Plain-English summary
BVI CustomEyes Procedure Packs containing certain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) are subject to a voluntary recall. The affected procedure packs contain low dead space and luer slip tip 1ml syringes with Part Number 58000192.
A total of 84 units have been distributed nationwide in the United States. The affected lot number is 6071161, and the UDI-DI is 30886158009963.
Consumers, healthcare facilities, and distributors in possession of BVI CustomEyes Procedure Packs with Part Number 58000192 should contact Beaver Visitec International, Inc. for guidance on returning or replacing affected procedure packs.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 84
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: 58000192
- UDI-DI: 30886158009963
- Lot/Batch Number: 6071161
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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