The Recall Desk
ModerateFDA (Devices)·Z-2828-2024·Announced 2024-09-04

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

Beaver Visitec International is recalling 59 BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

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 text explicitly describes this as a voluntary recall of syringes without reporting any illnesses, injuries, or specific defects, which aligns with the rubric for voluntary precautionary recalls.

Plain-English summary

Beaver Visitec International, Inc. is recalling 59 units of BVI CustomEyes Procedure Packs, Part Number 58000828. 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-Millennium Medical is voluntarily recalling low dead space syringes and luer slip tip syringes. The Sol-M syringes are present in some of the BVI CustomEyes Procedure Packs.

The affected products were distributed nationwide in the United States. The specific lot number is 6071164 and the UDI-DI is 30886158020746. Users should stop using these specific procedure packs and contact the manufacturer for further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000828;
Affected units
59

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: 58000828
  • UDI-DI: 30886158020746
  • Lot/Batch Number: 6071164

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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