The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2783-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 584545) nationwide. The recall is voluntary.

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: FDA Class II device subject to a voluntary recall with no specified hazard or reported illnesses/injuries. Per the recall severity rubric, voluntary precautionary recalls without stated adverse events score as Moderate.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled nationwide. The affected product (Part Number 584545, Lot Number 6074344, UDI-DI: 30886158140710) contains low dead space and luer slip tip 1 ml syringes manufactured by Sol-Millennium Medical, Inc.

This is a voluntary recall of the syringes included in the CustomEyes Procedure Packs. The source documentation does not specify the underlying reason for the Sol-M syringe recall. The product was distributed throughout the United States, affecting 18 units.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584545;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic / Syringes
Hazard
Affected units
18

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: 584545
  • UDI-DI: 30886158140710
  • Lot/Batch Number: 6074344

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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