The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2913-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc.

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 an FDA Class II medical device recall initiated voluntarily by the manufacturer. The source text does not specify a hazard, describe any illnesses or injuries, or explain the underlying cause of the recall. Voluntary precautionary recalls of Class II devices without reported serious adverse events correspond to Moderate severity.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs (Part Number 58001775) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The affected lot/batch numbers are 6067403 and 6070758.

Approximately 620 units of the affected procedure packs have been distributed nationwide throughout the United States. This is a voluntary recall initiated by Beaver Visitec International.

The specific reason for the recall is not specified in the available recall information. No hazards, adverse events, illnesses, or injuries are described in the recall notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001775;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Affected units
620

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 (4)

  • Part Number: 58001775
  • UDI-DI: 30886158032800
  • Lot/Batch Number: 6067403
  • 6070758

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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