The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2809-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Components

BVI CustomEyes Procedure Packs containing Sol-M syringes are subject to a voluntary recall. The recall affects 45 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 precautionary recall. No specific hazard or illnesses are described in the source. Classified as Moderate per the rubric criterion for voluntary precautionary recalls, rather than Low, due to the medical device classification and Class II status.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes are subject to a voluntary recall. The procedure packs are manufactured by Beaver Visitec International, Inc. and contain syringe components produced by Sol-Millennium Medical (Sol-M), Inc. The recalled product is identified by Part Number 58000477 and Lot Number 6072535.

The affected packs have been distributed nationwide throughout the United States. A total of 45 units are included in this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000477;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes / Procedure Packs
Affected units
45

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: 58000477
  • UDI-DI: 30886158019115
  • Lot/Batch Number: 6072535

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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