The Recall Desk
ModerateFDA (Devices)·Z-2825-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Subject to Recall

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes that are subject to a voluntary manufacturer recall. Approximately 260 units are affected 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 recall with no reported illnesses, injuries, or deaths. The voluntary, precautionary nature of the recall absent any reported harm meets the criteria for Moderate severity.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58000789) because they contain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) that are subject to a voluntary recall by the manufacturer. The affected syringes are low dead space and luer slip tip 1ml syringes, with lot numbers 6048500 and 6049553.

The affected products were distributed nationwide across the United States. Approximately 260 units are included in this recall. Customers who have received affected BVI CustomEyes Procedure Packs should discontinue use of the recalled syringes and contact Beaver Visitec International for instructions on return or replacement.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000789;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-defect

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: 58000789
  • UDI-DI: 30886158020395
  • Lot/Batch Number: 6048500
  • 6049553

Distribution

Distributed nationwide across the United States.