The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2799-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Due to Supplier Syringe Recall

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes following the manufacturer's voluntary recall of these 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 voluntary recall of medical syringes with no reported illnesses or injuries. The rubric identifies 'voluntary precautionary recalls' as warranting Moderate severity, and the source discloses no specific hazard details that would elevate the classification.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000168) are being recalled by Beaver Visitec International, Inc.

The recall follows a voluntary recall of these syringes by their manufacturer, Sol-Millennium Medical (Sol-M), Inc. Approximately 117 units of the affected product were distributed nationwide in the United States.

Consumers who have received these procedure packs are advised to stop using them and contact their healthcare provider or Beaver Visitec International for further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000168;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Hazard
Affected units
117

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: 58000168
  • UDI-DI: 30886158009574
  • Lot/Batch Number: 6072077

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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