The Recall Desk
ModerateFDA (Devices)·Z-2813-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntary Recall

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary manufacturer recall of those components.

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 hospitalizations mentioned in the source material. The specific hazard rationale is not detailed in the provided text.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The syringes are subject to a voluntary recall issued by the manufacturer.

The recalled procedure packs were distributed nationwide in the United States. The recall affects Part Number 58000567, with Lot/Batch Number 6064890. Approximately 211 units were distributed.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000567;
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: 58000567
  • UDI-DI: 30886158019306
  • Lot/Batch Number: 6064890

Distribution

Distributed nationwide across the United States.