The Recall Desk
ModerateFDA (Devices)·Z-2934-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall initiated by the syringe manufacturer. 76 units affected 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 medical device recall with no reported illnesses, injuries, or hospitalizations. The recall is voluntary and precautionary in nature, with no specific hazard detailed in the source material. Per the rubric, voluntary precautionary recalls without reported incidents are classified as Moderate.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58002042) that contain Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical, Inc.

The recall is in response to a voluntary recall of the Sol-M syringes by their manufacturer. Specific details regarding the defect or reason for the recall have not been disclosed in the recall notice.

Approximately 76 units of the affected procedure packs were distributed nationwide in the United States. The affected product has UDI-DI 30886158034309 and Lot Number 6073501.

If you have BVI CustomEyes Procedure Packs with part number 58002042, contact Beaver Visitec International, Inc. or your distributor for instructions regarding return or replacement of the affected units.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;
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: 58002042
  • UDI-DI: 30886158034309
  • Lot/Batch Number: 6073501

Distribution

Distributed nationwide across the United States.