The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2884-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 58001554) due to manufacturing concerns with the syringe components.

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 FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The recall fits the pattern of voluntary precautionary recalls without documented adverse events.

Plain-English summary

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58001554, Lot 6071824) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.

The recall was initiated voluntarily in response to the identification of these syringe components within the procedure packs.

The affected procedure packs were distributed nationwide across the United States, with approximately 6 units subject to this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001554;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Surgical Supplies
Hazard
Affected units
6

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: 58001554
  • UDI-DI: 30886158024553
  • Lot/Batch Number: 6071824

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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