The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2868-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs With Recalled Sol-M Syringes

BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. The affected products are 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 FDA Class II recall involves procedure packs containing syringes recalled by their manufacturer. No illnesses, injuries, or hospitalizations are reported in the source. The recall is voluntary and precautionary in nature, consistent with the rubric's criteria for Score 2.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The procedure packs contain low dead space and luer slip tip syringes manufactured by Sol-M, which are subject to a voluntary recall.

The affected procedure packs have been distributed nationwide in the United States. The recalled product is identified as BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number 58001395, Lot Number 6070544.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001395;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Injection Devices
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: 58001395
  • UDI-DI: 30886158023815
  • Lot/Batch Number: 6070544

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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