The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2892-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs With Sol-M Syringes Recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 478 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: FDA Class II voluntary recall with no reported illnesses, injuries, or hospitalizations. The absence of a specified hazard in the notice indicates a precautionary recall measure.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes. The recalled procedure packs contain Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These are low dead space and luer slip tip syringes with Part Number 58001624, UDI-DI 30886158031865, and Lot Number 6064651.

The recall affects 478 units distributed nationwide in the United States. This is a Class II FDA recall. The specific hazard or concern that prompted the recall is not detailed in the public notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device
Hazard
Affected units
478

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: 58001622
  • UDI-DI: 30886158031865
  • Lot/Batch Number: 6064651

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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