The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2801-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Defective Sol-M Syringes Recalled Nationwide

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain defective syringes made by Sol-Millennium Medical. The voluntary recall affects 149 units distributed nationwide.

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: This is a voluntary Class II recall with no reported illnesses or injuries mentioned in the source. The FDA classification and voluntary precautionary nature of the recall, combined with the absence of reported harm, fit the rubric criterion for Moderate severity.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs due to a voluntary recall of syringes they contain. The procedure packs hold Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc., with Part Number 58000195, UDI-DI 30886158009765, and Lot Number 6071454.

A total of 149 units of the affected procedure packs were distributed nationwide throughout the United States. Customers who possess these packs should stop using them and contact Beaver Visitec International for return or replacement instructions. Users uncertain whether their inventory is affected should verify the part number and lot number against the information provided in this notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000195;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Injectable Device
Hazard
Affected units
149

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: 58000195
  • UDI-DI: 30886158009765
  • Lot/Batch Number: 6071454

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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