The Recall Desk
ModerateFDA (Devices)·Z-2851-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical due to a supplier voluntary recall affecting 71 units nationwide.

What this means for you

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 Class II medical device recall with no reported illnesses, injuries, or deaths. The recall is described as voluntary and precautionary in nature. Per FDA severity rubric, voluntary precautionary recalls receive a Moderate rating.

Plain-English summary

BVI CustomEyes Procedure Packs containing low dead space and luer slip 1ml syringes (Part Number 58001177) manufactured by Sol-Millennium Medical (Sol-M), Inc. are being recalled by Beaver Visitec International. The recall is due to a voluntary recall of the syringes initiated by Sol-M.

The affected syringes are present in some BVI CustomEyes Procedure Packs distributed nationwide. Approximately 71 units were affected. The affected lot is identified by Lot/Batch Number 6074599, UDI-DI 30886158023822, and Part Number 58001177.

Consumers and healthcare providers who have received the recalled procedure packs should contact Beaver Visitec International for instructions regarding the affected product. The specific hazard prompting the supplier's recall has not been detailed in this notice.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001177;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Supplies / Syringes
Hazard
Affected units
71

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: 58001177
  • UDI-DI: 30886158023822
  • Lot/Batch Number: 6074599

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 →

Related recalls

Same manufacturer · Beaver Visitec International, Inc.

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Same hazard · syringe defect

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