The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2781-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. due to a manufacturer's voluntary recall. 659 units are affected 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 a Class II medical device recall initiated voluntarily by the component manufacturer. No specific hazard is detailed in the notice, and no illnesses or injuries are reported, meeting the criteria for a voluntary precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. The recalled packs (Part Number: 584003, Lot: 6063717) total 659 units and have been distributed nationwide.

Sol-Millennium Medical, Inc., the syringe manufacturer, initiated a voluntary recall of these specific syringe models, and Beaver Visitec is therefore recalling the BVI CustomEyes Procedure Packs that contain these syringes.

Consumers and healthcare facilities who have received affected packs should contact Beaver Visitec International, Inc. for instructions. The packs should not be used until further guidance is received from the manufacturer.

For additional information, contact the manufacturer or visit the FDA website.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Procedure Packs
Hazard
Affected units
659

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: 584003
  • UDI-DI: 30886158141496
  • Lot/Batch Number: 6063717

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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