The Recall Desk
ModerateFDA (Devices)·Z-2910-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing 1ml syringes manufactured by Sol-Millennium Medical, Inc., distributed nationwide in the United States.

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 recall with no reported illnesses, injuries, or deaths. Per the severity rubric, voluntary precautionary recalls without any reported adverse events are classified as Moderate (Score 2).

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling specific BVI CustomEyes Procedure Packs (Part Number 58001753, UDI-DI 30886158032497, Lot 6074601) that contain low dead space and luer slip tip 1ml syringes manufactured by Sol-Millennium Medical, Inc. The recalled product has been distributed nationwide across the United States.

The voluntary recall was initiated due to the presence of syringes manufactured by Sol-Millennium Medical, Inc. that are included in these procedure packs. This is an FDA Class II recall involving components of ophthalmic surgical procedure packages.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001753;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Supplies
Hazard
Affected units
10

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: 58001753
  • UDI-DI: 30886158032497
  • Lot/Batch Number: 6074601

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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Same manufacturer · Beaver Visitec International, Inc.

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