The Recall Desk
ModerateFDA (Devices)·Z-2859-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes (Part Number 58001331, Lot 6069181). The voluntary recall affects approximately 357 units distributed nationwide.

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 an FDA Class II voluntary precautionary recall with no reported illnesses, injuries, or deaths. Per the rubric, voluntary precautionary recalls without reported harm are scored as Moderate (2).

Plain-English summary

Beaver Visitec International (BVI) is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recalled procedure packs contain low dead space syringes and luer slip tip syringes with Part Number 58001331, Lot/Batch Number 6069181 (UDI-DI: 30886158023532). Approximately 357 units were distributed nationwide in the United States.

This is a voluntary recall issued by BVI. The procedure packs containing these specific Sol-M syringes have been recalled.

The affected procedure packs are used in ophthalmic (eye) surgical procedures. Healthcare facilities and providers should check their inventory for the specified part number and lot number to identify affected units in their possession.

If you have received or used these procedure packs, contact Beaver Visitec International for further guidance on product replacement or disposal options.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001331;
Affected units
357

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: 58001331
  • UDI-DI: 30886158023532
  • Lot/Batch Number: 6069181

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 →

Same manufacturer · Beaver Visitec International, Inc.

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