The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2823-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with defective Sol-M syringes recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. These 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 recall with no reported illnesses, injuries, or hospitalizations. The voluntary nature of the recall and lack of reported harm align with the rubric's definition of voluntary precautionary recalls as Moderate (2).

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58000775) that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The affected lot is Batch Number 6070132 (UDI-DI: 30886158020319), with 40 units distributed.

These procedure packs were distributed nationwide throughout the United States. The syringes present in the packs are the subject of the voluntary recall initiated by Sol-M.

Patients and healthcare providers in possession of these procedure packs should contact Beaver Visitec International for information regarding the recall and any remedial actions.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical / Ophthalmic
Hazard
Affected units
40

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: 58000775
  • UDI-DI: 30886158020319
  • Lot/Batch Number: 6070132

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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