The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2906-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) syringes, affecting 126 units distributed nationwide. The recall was initiated following a manufacturer 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: This is a Class II recall with no reported illnesses or injuries. The recall was initiated voluntarily by the manufacturer in response to a syringe manufacturer recall, fitting the criterion for voluntary precautionary recalls.

Plain-English summary

Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs (Part Number 58001712, Lot 6074820, UDI-DI: 30886158032428) that contain low dead space and Luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The FDA has classified this as a Class II recall. A total of 126 units were distributed throughout the United States.

The recall was initiated by Beaver Visitec International in response to a recall of these syringes by their manufacturer, Sol-Millennium Medical, Inc.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001712;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Syringes
Hazard
Affected units
126

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: 58001712
  • UDI-DI: 30886158032428
  • Lot/Batch Number: 6074820

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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