The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2873-2024·Announced 2024-09-04

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

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 safety hazards, which aligns with the rubric for voluntary precautionary recalls.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain Sol-M Luer Lock and Luer Slip 1ml syringes. The recall is being conducted because the syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. are subject to a voluntary recall.

The affected products are identified by Part Number 58001478, UDI-DI 30886158024317, and Lot/Batch Number 6069663. A total of 580 units were distributed nationwide in the United States.

Healthcare facilities and consumers should stop using these specific procedure packs and contact the recalling firm for instructions on how to return or dispose of the affected units.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001478;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Hazard
Affected units
580

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: 58001478
  • UDI-DI: 30886158024317
  • Lot/Batch Number: 6069663

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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