The Recall Desk
ModerateFDA (Devices)·Z-2784-2024·Announced 2024-09-04

FDA recalls BVI CustomEyes ophthalmic procedure packs nationwide

Beaver Visitec International initiated a voluntary recall of BVI CustomEyes Procedure Packs containing surgical syringes (Part Number 584550, Lot 6048601) distributed nationwide. The Class II recall was initiated on July 26, 2024.

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 medical device recall initiated voluntarily by the manufacturer with no reported adverse events, injuries, or hospitalizations in the source material. Voluntary precautionary recalls without reported harm are classified as Moderate per the severity rubric.

Plain-English summary

Beaver Visitec International, Inc., has recalled BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes. The affected product has Part Number 584550 and Lot Number 6048601. A total of 4 units were distributed nationwide in the United States.

This is a voluntary, firm-initiated Class II recall initiated on July 26, 2024. The FDA Class II classification indicates that the product could potentially cause serious adverse health consequences.

Healthcare facilities and individuals in possession of the affected product should discontinue use immediately. Contact Beaver Visitec International, Inc., or the FDA for additional information about the recall or to report any adverse events associated with this product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Syringes
Hazard
Affected units
4

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: 584550
  • UDI-DI: 30886158140758
  • Lot/Batch Number: 6048601

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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