The Recall Desk
ModerateFDA (Devices)·Z-2805-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing recalled Sol-M syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical that are subject to a manufacturer's voluntary recall. 388 units were 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: FDA Class II voluntary recall with no reported illnesses, injuries, or explicitly stated hazard. The precautionary nature and lack of reported harm places this in the Moderate category.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58000305) that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The syringes are the subject of a voluntary recall by the manufacturer.

The affected procedure packs contain low dead space and luer slip tip syringes. A total of 388 units were distributed nationwide. Affected lot numbers include 6060099, 6069182, and 6070757 (UDI-DI: 30886158013632).

Healthcare facilities and consumers should verify their inventory against the affected lot numbers to determine if they have received recalled units.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000305;
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 (5)

  • Part Number: 58000305
  • UDI-DI: 30886158013632
  • Lot/Batch Number: 6060099
  • 6069182
  • 6070757

Distribution

Distributed nationwide across the United States.