The Recall Desk
ModerateFDA (Devices)·Z-2810-2024·Announced 2024-09-04

BVI Recalls CustomEyes Procedure Packs Containing Sol-M Syringes

Beaver Visitec International (BVI) is recalling CustomEyes Procedure Packs because they contain Sol-Millennium Medical (Sol-M) syringes that Sol-M has voluntarily recalled.

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 with no reported illnesses, injuries, or hospitalizations. The recall is voluntary and precautionary in nature, initiated due to Sol-M's recall of the syringes, without specific hazard details provided in the source.

Plain-English summary

Beaver Visitec International (BVI) is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000479). The recalled procedure packs contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.

Approximately 162 units of the affected procedure packs were distributed nationwide in the United States.

The recall is due to Sol-M's voluntary recall of low dead space syringes and Luer slip tip syringes. BVI is recalling its procedure packs as a precautionary measure because they contain the Sol-M syringes involved in that recall.

Healthcare facilities and practitioners who have received the affected CustomEyes Procedure Packs should discontinue use and contact Beaver Visitec International for return or replacement options. The affected lot numbers are 6071531 and 6073788.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000479;
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 (4)

  • Part Number: 58000479
  • UDI-DI: 30886158019108
  • Lot/Batch Number: 6071531
  • 6073788

Distribution

Distributed nationwide across the United States.