The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2935-2024·Announced 2024-09-04

Beaver Visitec recalls CustomEyes Procedure Packs containing Sol-Millennium syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs nationwide that contain syringes manufactured by Sol-Millennium Medical, which are subject to a separate voluntary recall.

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 with no reported illnesses or injuries. Voluntary recall fits the 'voluntary precautionary recalls' criterion for Moderate severity.

Plain-English summary

BVI CustomEyes Procedure Packs contain syringes manufactured by Sol-Millennium Medical (Sol-M) that are subject to a voluntary recall. The affected procedure packs include low dead space Luer Lock and Luer Slip 1ml syringes manufactured by Sol-M.

The recall involves procedure packs with Part Number 58002063 and Lot Number 6074347. These packs have been distributed nationwide in the United States.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002063;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic surgical supplies
Hazard
Affected units
5

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: 58002063
  • UDI-DI: 30886158034453
  • Lot/Batch Number: 6074347

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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