The Recall Desk
ModerateFDA (Devices)·Z-2932-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are being recalled in a voluntary action. 207 units with Part Number 58001999 are 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 an FDA Class II medical device recall described as voluntary precautionary in nature. No illnesses, injuries, or specific hazards are reported in the source material. Voluntary precautionary recalls warrant Moderate severity per the FDA classification rubric.

Plain-English summary

BVI CustomEyes Procedure Packs contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc., which are subject to a voluntary recall. These syringes are incorporated into procedure packs distributed nationwide in the United States.

The recalled product has Part Number 58001999, UDI-DI 30886158034019, and Lot/Batch Number 6072061. A total of 207 units have been distributed. The recalling firm is Beaver Visitec International, Inc.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001999;
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: 58001999
  • UDI-DI: 30886158034019
  • Lot/Batch Number: 6072061

Distribution

Distributed nationwide across the United States.