The Recall Desk
ModerateFDA (Devices)·Z-2917-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall

Beaver Visitec International is recalling 236 units of BVI CustomEyes Procedure Packs containing syringes that have been voluntarily recalled by their manufacturer, Sol-M.

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 initiated as a voluntary action by the syringe manufacturer with no reported illnesses or injuries.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recall is due to a voluntary recall of the Sol-M syringes, specifically low dead space and luer slip tip syringe models.

The recalled procedure packs have a total quantity of 236 units, distributed nationwide in the United States. The affected packs are identified by Part Number 58001825, Lot Number 6074001, and UDI-DI 30886158032893.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001825;
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: 58001825
  • UDI-DI: 30886158032893
  • Lot/Batch Number: 6074001

Distribution

Distributed nationwide across the United States.