BVI CustomEyes Procedure Packs containing Sol-M syringes recalled nationwide
Procedure packs containing Sol-M manufactured syringes are being voluntarily recalled nationwide. The affected product is part number 58000603.
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: This is a Class II voluntary recall with no reported illnesses or injuries. The voluntary precautionary nature and absence of any reported harm incidents place this in the Moderate category per the recall severity rubric, which explicitly identifies voluntary precautionary recalls as Moderate severity.
Plain-English summary
BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are subject to a voluntary recall. The affected procedure packs contain Luer Lock and Luer Slip 1ml syringes (Part Number 58000603, Lot Number 6069800).
The recall was initiated due to concerns with the Sol-M manufactured syringes included in these procedure packs. The procedure packs have been distributed nationwide in the United States, affecting 54 units.
Individuals or organizations that have received these BVI CustomEyes Procedure Packs should check their inventory to determine if they possess the recalled product. Those who have the affected procedure packs should contact Beaver Visitec International, Inc. for further instructions.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000603;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 54
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: 58000603
- UDI-DI: 30886158019436
- Lot/Batch Number: 6069800
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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