The Recall Desk
ModerateFDA (Devices)·Z-2895-2024·Announced 2024-09-04

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

Beaver Visitec International is recalling 42 units of BVI CustomEyes Procedure Packs because they contain Sol-M syringes subject to a separate 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: The source describes a voluntary recall of medical devices without reporting any illnesses, injuries, or specific safety hazards, which aligns with the rubric for voluntary precautionary recalls.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling 42 units of BVI CustomEyes Procedure Packs, Part Number 58001634. These procedure packs contain Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.

The recall is being conducted because Sol-M is voluntarily recalling its low dead space syringes and luer slip tip syringes. The BVI CustomEyes Procedure Packs are affected because they include these specific Sol-M syringes.

The affected products were distributed nationwide in the United States. The specific lot number is 6073601, and the UDI-DI is 30886158031698. Healthcare providers and consumers should check their inventory for this specific part number and lot number. If found, the products should be removed from use and returned to the distributor or manufacturer in accordance with the recall instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001634;
Affected units
42

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: 58001634
  • UDI-DI: 30886158031698
  • Lot/Batch Number: 6073601

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 159 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 159 products in this recall →

Same manufacturer · Beaver Visitec International, Inc.

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