The Recall Desk
ModerateFDA (Devices)·Z-2888-2024·Announced 2024-09-04

Syringe Recall: BVI CustomEyes Procedure Packs Distributed Nationwide

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M syringes. The affected packs, which contain low dead space and luer slip 1ml syringes, were 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 voluntary FDA Class II recall of medical device syringes with no reported illnesses or injuries. The source does not specify the underlying hazard, suggesting a precautionary measure.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The affected packs contain 1ml low dead space Luer Lock and Luer Slip syringes (Part Number 58001605).

The recall was initiated in response to a voluntary recall of the Sol-M syringes. Approximately 80 units of the affected procedure packs were distributed nationwide, with lot number 6062364.

Healthcare providers and medical facilities that received these procedure packs should discontinue use and contact Beaver Visitec International for instructions on return or replacement.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;
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: 58001605
  • UDI-DI: 30886158031520
  • Lot/Batch Number: 6062364

Distribution

Distributed nationwide across the United States.