The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2833-2024·Announced 2024-09-04

FDA Recalls BVI CustomEyes Procedure Packs Containing Sol-M Syringes

The FDA has issued a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes. Approximately 8 units have been 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 is a Class II medical device recall with voluntary status. No patient illnesses, injuries, or deaths are reported in the source, and the specific hazard is not detailed.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000921, Lot 6073120) are subject to a voluntary recall. The recall involves syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. that are present in some BVI CustomEyes Procedure Packs.

Approximately 8 units of the affected product have been distributed nationwide. The specific reason for the recall is not detailed in the agency announcement.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000921;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Syringes
Hazard
Affected units
8

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: 58000921
  • UDI-DI: 30886158021309
  • Lot/Batch Number: 6073120

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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