The Recall Desk
ModerateFDA (Devices)·Z-2933-2024·Announced 2024-09-04

FDA recalls Sol-M syringes in BVI CustomEyes Procedure Packs

Beaver Visitec International is voluntarily recalling 133 units of BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical. The Class II recall affects units distributed nationwide.

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 voluntary Class II medical device recall with no reported illnesses, injuries, or documented safety incidents in the source material. Voluntary precautionary recalls without reported harm are classified as Moderate severity.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recalled product is identified by Part Number 58002000, Lot Number 6071764, and UDI-DI 30886158034026.

The recall affects 133 units of the procedure packs that were distributed nationwide throughout the United States.

Healthcare providers and consumers who have received these procedure packs should contact Beaver Visitec International, Inc. for additional information and instructions regarding the recall and proper disposition of the product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;
Manufacturer
Beaver Visitec International, Inc.

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: 58002000
  • UDI-DI: 30886158034026
  • Lot/Batch Number:6071764

Distribution

Distributed nationwide across the United States.