The Recall Desk
ModerateFDA (Devices)·Z-2786-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall by the syringe manufacturer. The affected procedure packs 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: FDA Class II medical device recall described as voluntary with no specific hazard identified or illness/injury reports mentioned in the source material, consistent with precautionary recalls.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain Sol-M low dead space and luer slip tip syringes. The affected procedure packs, identified by Part Number 584625 and Lot Number 6074323, were distributed nationwide throughout the United States.

The recall was initiated in response to a voluntary recall by Sol-Millennium Medical (Sol-M), Inc., the manufacturer of the syringes. The specific hazard or medical reason for the manufacturer's recall is not specified in the available recall information.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584625;
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: 584625
  • UDI-DI: 30886158141502
  • Lot/Batch Number: 6074323

Distribution

Distributed nationwide across the United States.