The Recall Desk
ModerateFDA (Devices)·Z-2860-2024·Announced 2024-09-04

Syringes in BVI CustomEyes Procedure Packs Recalled Nationwide

Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The specific reason for the recall is not detailed in the FDA notice.

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 recall with no reported illnesses or injuries. The specific hazard is not articulated in the source material. Per the rubric, voluntary precautionary recalls are classified as Score 2 (Moderate).

Plain-English summary

Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs that contain low dead space syringes and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.

The recalled packs have Part Number 58001338 and Lot/Batch Number 6074329. A total of 64 units were distributed nationwide in the United States.

No specific defect or hazard is detailed in the recall notice. Consumers should stop using the affected packs and contact the recalling manufacturer for replacement or return.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338;
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 (3)

  • Part Number: 58001338
  • UDI-DI: 30886158023785
  • Lot/Batch Number: 6074329

Distribution

Distributed nationwide across the United States.