The Recall Desk
ModerateFDA (Devices)·Z-2826-2024·Announced 2024-09-04

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

Beaver Visitec International is recalling 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 recall is classified as FDA Class II and is described as a voluntary precautionary recall of components without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs, Part Number 58000803, that contain Sol-M Luer Lock and Luer Slip 1ml syringes. The recall involves 108 units distributed nationwide in the United States.

The recall is being conducted because the Sol-M syringes included in these packs are subject to a voluntary recall by the manufacturer, Sol-Millennium Medical (Sol-M), Inc. The source text does not specify the exact nature of the defect in the syringes or any reported injuries or illnesses associated with the use of these products.

Healthcare providers and consumers should stop using the affected BVI CustomEyes Procedure Packs and contact the recalling firm for instructions on how to return or dispose of the products. The specific lot number for the affected units is 6069183.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000803;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Hazard
Affected units
108

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: 58000803
  • UDI-DI: 30886158020517
  • Lot/Batch Number: 6069183

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 →

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Same manufacturer · Beaver Visitec International, Inc.

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Same hazard · component defect

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