The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2882-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall by the manufacturer. The procedure packs were 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 is an FDA Class II medical device recall with no reported illnesses or injuries. The recall is voluntary and precautionary in nature, meeting the criteria for a moderate-severity voluntary precautionary recall.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs (Part Number 58001545) that contain Sol-Millennium Medical (Sol-M) manufactured syringes. The affected procedure packs are distributed nationwide in the United States, with 110 units identified in this recall.

Sol-Millennium Medical initiated a voluntary recall of low dead space syringes and luer slip tip syringes that are included in some BVI CustomEyes Procedure Packs. These syringes are used in ophthalmic procedures.

Affected lot and batch numbers are 6062861 and 6064638. Healthcare facilities and medical professionals who have received these procedure packs are advised to review these lot numbers to determine if they have been affected by this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001545;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Procedure Packs
Hazard
Affected units
110

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 (4)

  • Part Number: 58001545
  • UDI-DI: 30886158031995
  • Lot/Batch Number: 6062861
  • 6064638

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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