The Recall Desk
ModerateFDA (Devices)·Z-2914-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain Sol-M low dead space and luer slip syringes. The recall affects 150 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: This is a Class II voluntary medical device recall with no reported illnesses or injuries. The specific hazard is not detailed in the source, indicating a precautionary measure.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip 1ml syringes. These syringes are manufactured by Sol-Millennium Medical (Sol-M), Inc. and are included in some BVI CustomEyes Procedure Packs (Part Number 58001795).

The recall affects 150 units distributed nationwide in the United States. The affected units are identified by UDI-DI 30886158033340 and Lot/Batch Number 6074613.

This is a voluntary Class II recall of these medical device components.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001795;
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: 58001795
  • UDI-DI: 30886158033340
  • Lot/Batch Number: 6074613

Distribution

Distributed nationwide across the United States.