The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2788-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Due to Component Syringe Issue

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical that are subject to recall. The affected packs were distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 of a medical device component. The source text does not specify a particular defect or report any illnesses or injuries. Per the severity rubric, voluntary precautionary recalls without reported harm are classified as Moderate.

Plain-English summary

Beaver Visitec International, Inc. (BVI) is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 584643). The recall was initiated due to a concurrent voluntary recall of these component syringes by their manufacturer, Sol-Millennium Medical (Sol-M), Inc.

The affected procedure packs carry lot number 6068270 and UDI-DI 30886158141717. A total of 40 units were distributed nationwide in the United States. Affected facilities and consumers who have obtained these procedure packs should take appropriate action regarding the recalled product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584643;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical / Ophthalmic Supplies
Hazard
Affected units
40

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: 584643
  • UDI-DI: 30886158141717
  • Lot/Batch Number: 6068270

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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