The Recall Desk
HighFDA (Devices)·Z-2829-2024·Announced 2024-09-04

Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes

BVI CustomEyes Procedure Packs containing Sol-M manufactured low dead space and Luer Slip syringes are subject to a voluntary recall. Approximately 142 units were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall, indicating FDA determined the possibility of serious adverse health consequences. However, no illnesses or injuries have been reported, and the source documentation does not specify the particular hazard. Per the rubric, when the hazard is theoretical and no harm has been reported, the score is at most 3.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain low dead space and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes are subject to a voluntary recall by Sol-Millennium Medical. Approximately 142 units of the affected procedure packs were distributed nationwide. The affected product part number is 58000866 with Lot/Batch Number 6074581 and UDI-DI 30886158021132.

BVI initiated this recall because the syringes manufactured by Sol-M that are included in their procedure packs are part of Sol-M's voluntary recall. The specific technical issue with these syringes is not detailed in the recall notice.

Healthcare providers and facilities that have received BVI CustomEyes Procedure Packs with the affected lot number should discontinue use and contact Beaver Visitec International for further instructions. When contacting the manufacturer, reference part number 58000866 and lot number 6074581.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000866;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic
Hazard
Affected units
142

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: 58000866
  • UDI-DI: 30886158021132
  • Lot/Batch Number: 6074581

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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