The Recall Desk
ModerateFDA (Devices)·Z-2879-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

BVI CustomEyes Procedure Packs containing Sol-M syringes have been voluntarily recalled. Users of affected packs should discontinue use and contact the manufacturer.

What this means for you

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 precautionary recall with no reported illnesses, injuries, or hospitalizations. FDA Class II medical device recalls without reported adverse events are classified as Moderate severity.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58001521, Lot 6071460) are subject to a voluntary recall. Approximately 20 units were distributed nationwide in the United States.

The recall was initiated following a voluntary recall by Sol-Millennium Medical (Sol-M), Inc., the manufacturer of the syringes contained in these procedure packs. The specific defect or hazard associated with the syringes is not detailed in this recall notice.

Healthcare facilities and providers who received affected procedure packs should discontinue use and contact Beaver Visitec International, Inc. for further instructions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001521;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Surgical
Hazard
Affected units
20

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: 58001521
  • UDI-DI: 30886158024690
  • Lot/Batch Number: 6071460

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 →

Related recalls

Same manufacturer · Beaver Visitec International, Inc.

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Same hazard · device defect

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