The Recall Desk
ModerateFDA (Devices)·Z-2875-2024·Announced 2024-09-04

Beaver Visitec Recalls CustomEyes Procedure Packs with Sol-M Syringes

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M. Approximately 1,338 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 precautionary recall with no reported illnesses, injuries, or deaths stated in the source. The source does not specify a particular defect or hazard.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing low dead space Luer lock and Luer slip tip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes are present in some of the CustomEyes Procedure Packs.

The recalled products were distributed nationwide in the United States. Affected units can be identified by Part Number 58001486, UDI-DI 30886158033746, and Lot/Batch Numbers 6071440 or 6074586. Approximately 1,338 units have been identified as subject to recall.

Consumers and healthcare facilities should cease use of the affected CustomEyes Procedure Packs immediately. Those who have used the affected products and have concerns about their health should consult a healthcare provider. For additional information or to report adverse events, contact Beaver Visitec International or the FDA.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • defective-device

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: 58001486
  • UDI-DI: 30886158033746
  • Lot/Batch Number: 6071440
  • 6074586

Distribution

Distributed nationwide across the United States.