The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2909-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 98 units 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 a voluntary FDA Class II recall with no reported illnesses or injuries. No specific hazard or defect has been detailed in the recall notice, and the voluntary nature suggests a precautionary action.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs that contain Sol-M low dead space and luer slip tip syringes. The recalled procedure packs are identified by Part Number 58001737 and were distributed nationwide.

The recall affects approximately 98 procedure packs. The involved syringes are 1ml Luer Lock and Luer Slip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected lot numbers are 6064860 and 6069172.

These procedure packs are used in ophthalmic procedures and consist of components including the recalled syringes.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Ophthalmic Procedure Packs
Hazard
Affected units
98

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: 58001737
  • UDI-DI: 30886158032480
  • Lot/Batch Number: 6064860
  • 6069172

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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