The Recall Desk
ModerateFDA (Devices)·Z-2793-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes as a voluntary Class II recall. The recall affects 103 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 an FDA Class II voluntary recall with no reported illnesses or injuries. The hazard is not specified in the source. According to the rubric, voluntary precautionary recalls are classified as Moderate (Score 2).

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) Luer Lock and Luer Slip 1ml syringes. This voluntary FDA Class II recall involves 103 units of procedure packs that were distributed nationwide in the United States.

The recall was issued following a recall of these specific syringes by Sol-Millennium Medical. The affected procedure packs have Part Number 584785 and Batch Number 6075214 (UDI-DI: 30886158009000). The source notice does not specify the nature of the hazard or defect associated with the syringes.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584785;
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 (3)

  • Part Number: 584785
  • UDI-DI: 30886158009000
  • Lot/Batch Number: 6075214

Distribution

Distributed nationwide across the United States.