The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2890-2024·Announced 2024-09-04

Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. The affected packs were 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: This FDA Class II medical device recall involves no reported illnesses, injuries, or deaths. As a voluntary precautionary recall without documented adverse events, it meets the criteria for Moderate severity.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The recalled product contains Sol-M Luer Lock and Luer Slip 1ml syringes, identified by Part Number 58001609 and Lot Number 6064451.

Approximately 82 units of these procedure packs have been distributed throughout the United States. The specific hazard or reason for the recall has not been detailed in the recall notice. This is a voluntary recall conducted by the manufacturer.

Consumers and healthcare facilities who have received or used these recalled procedure packs should contact Beaver Visitec International for instructions on how to proceed with the affected product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Syringes
Hazard
Affected units
82

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: 58001609
  • UDI-DI: 30886158031544
  • Lot/Batch Number: 6064451

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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