The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2858-2024·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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 describes a voluntary recall of syringe components without reporting any illnesses, injuries, or specific high-risk hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs, Part Number 58001315, which contain Sol-M Luer Lock and Luer Slip 1ml syringes. The recall involves 153 units distributed nationwide in the United States.

The recall is being conducted because Sol-Millennium Medical (Sol-M), Inc. is voluntarily recalling the specific low dead space and luer slip tip syringes included in these procedure packs. The source text does not specify the exact nature of the defect in the Sol-M syringes or report any illnesses or injuries associated with the use of these products.

Healthcare providers and consumers should stop using the affected BVI CustomEyes Procedure Packs and follow instructions from the recalling firm or the FDA regarding the return or disposal of the product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001315;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Hazard
Affected units
153

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: 58001315
  • UDI-DI: 30886158023389
  • Lot/Batch Number: 6071469

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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