The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2911-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Nationwide for Syringe Defects

Beaver Visitec International has recalled 115 units of BVI CustomEyes Procedure Packs containing Sol-M syringes distributed nationwide. The voluntary recall addresses a manufacturing issue with the syringes included in the procedure packs.

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, precautionary recall of a Class II medical device with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (score 2).

Plain-English summary

Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001764, Lot 6072080) that contain Sol-M Luer Lock and Luer Slip 1ml syringes. These syringes are manufactured by Sol-Millennium Medical (Sol-M), Inc., which has initiated a voluntary recall of these syringe models.

The affected procedure packs have been distributed nationwide in the United States. A total of 115 units are included in this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001764;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Supplies
Hazard
Affected units
115

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: 58001764
  • UDI-DI: 30886158032435
  • Lot/Batch Number: 6072080

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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