The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2926-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M syringes recalled

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes 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 voluntary Class II FDA recall with no reported illnesses, injuries, or deaths. The source does not specify the underlying hazard, indicating this is a precautionary measure rather than a response to actual harm.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) manufactured syringes are being voluntarily recalled. The affected syringes are low dead space and luer slip tip models with Part Number 58001934, UDI-DI 30886158033562, and Lot Number 6070801. A total of 102 units were distributed nationwide.

The recall was initiated by Beaver Visitec International, Inc., the manufacturer of the procedure packs. The specific reason for the recall is not detailed in the public announcement.

Consumers and healthcare facilities who have received this product should discontinue use and contact Beaver Visitec International for further instructions regarding return or disposal of the affected procedure packs.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Procedure Packs
Hazard
Affected units
102

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: 58001934
  • UDI-DI: 30886158033562
  • Lot/Batch Number: 6070801

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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