The Recall Desk
ModerateFDA (Devices)·Z-2843-2024·Announced 2024-09-04

Syringes in BVI CustomEyes Procedure Packs Recalled Nationwide

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs nationwide because they contain low dead space and luer slip syringes manufactured by Sol-Millennium Medical that are subject to a voluntary recall.

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 recall is secondary, initiated because the procedure packs contain syringes from Sol-M that are subject to a separate voluntary recall. No specific hazards are detailed in the source material.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs due to the inclusion of syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) that are subject to a voluntary recall. The affected packs contain low dead space and luer slip tip syringes, Part Number 58001110.

The recalled products were distributed nationwide. The recall includes products with Lot Number 6073585.

Anyone who has received these procedure packs should contact Beaver Visitec International for information regarding the recalled products.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;
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: 58001110
  • UDI-DI: 30886158022177
  • Lot/Batch Number: 6073585

Distribution

Distributed nationwide across the United States.