The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2849-2024·Announced 2024-09-04

Beaver Visitec recalls CustomEyes Procedure Packs with Sol-M syringes

Beaver Visitec International is recalling 505 CustomEyes Procedure Packs containing Sol-Millennium Medical syringes that are subject to a voluntary manufacturer 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: This is a voluntary recall of Class II medical devices. The recall notice does not provide specific details about the underlying hazard, characterizing this as a precautionary recall.

Plain-English summary

Beaver Visitec International is recalling 505 units of BVI CustomEyes Procedure Packs (Part Number 58001174) containing 1ml Sol-M Luer Lock and Luer Slip syringes. The syringes were manufactured by Sol-Millennium Medical (Sol-M), Inc., which has issued a voluntary recall of these syringe products.

The recalled lot number is 6068288. These procedure packs were distributed nationwide in the United States.

Healthcare providers and users who have received affected procedure packs should contact Beaver Visitec International or their medical supplier for guidance regarding this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001174;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Supplies
Hazard
Affected units
505

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: 58001174
  • UDI-DI: 30886158022474
  • Lot/Batch Number: 6068288

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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