The Recall Desk
ModerateFDA (Devices)·Z-2789-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing syringes recalled nationwide

BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall affecting 73 units 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: The source indicates a voluntary, precautionary recall of medical device syringes without reported illnesses or injuries. FDA Class II classification applies, but without documented harm or clear hazard description, this meets the rubric criteria for a moderate-severity, precautionary recall.

Plain-English summary

BVI CustomEyes Procedure Packs containing low dead space and Luer slip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are being voluntarily recalled. The affected product has Part Number 584712 and Lot/Batch Number 6070547.

Approximately 73 units of the affected procedure packs were distributed across the United States.

The recalled product can be identified by UDI-DI 30886158142455.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584712;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • device-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 (3)

  • Part Number: 584712
  • UDI-DI: 30886158142455
  • Lot/Batch Number: 6070547

Distribution

Distributed nationwide across the United States.