The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2818-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Component

Beaver Visitec International recalled BVI CustomEyes Procedure Packs containing defective 1ml syringes manufactured by Sol-Millennium Medical. The 68-unit recall involves procedure packs distributed nationwide in the United States.

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: The recall is FDA Class II but involves a voluntary precautionary action with no reported illnesses, injuries, or deaths. The rubric explicitly assigns voluntary precautionary recalls to the Moderate category when no serious harm is documented.

Plain-English summary

Beaver Visitec International, Inc. issued a voluntary recall of BVI CustomEyes Procedure Packs containing 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs contain low dead space syringes with luer slip tip connectors. The recall involves 68 units (Part Number 58000709, Lot/Batch Number: 6069363, UDI-DI: 30886158019955).

The affected procedure packs were distributed nationwide throughout the United States. While the recall notice does not specify the reason for the recall or recommended consumer actions, affected facilities and users should seek additional information from Beaver Visitec International or the U.S. Food and Drug Administration regarding return or disposal procedures.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000709;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Procedure Pack
Hazard
Affected units
68

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: 58000709
  • UDI-DI: 30886158019955
  • Lot/Batch Number: 6069363

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 →

Related recalls

Same manufacturer · Beaver Visitec International, Inc.

See all →

Same hazard · device defect

See all →

Similar recalls