The Recall Desk
ModerateFDA (Devices)·Z-2937-2024·Announced 2024-09-04

FDA Recalls BVI CustomEyes Procedure Packs Containing Sol-M Syringes

Beaver Visitec International has voluntarily recalled 56 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes. The recall involves low dead space and luer slip tip syringes distributed 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 voluntary medical device recall. No reported illnesses or injuries are mentioned in the source, and the specific hazard is not explicitly stated. The voluntary nature and absence of reported harm classify this as a Moderate-severity recall.

Plain-English summary

Beaver Visitec International, Inc. is conducting a voluntary recall of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recalled packs contain low dead space syringes and luer slip tip syringes produced by Sol-M.

The affected products have Part Number 58002075 and UDI-DI 30886158034460. The recalled batch is identified as Lot/Batch Number 6074313 and consists of 56 units that were distributed nationwide throughout the United States.

The U.S. Food and Drug Administration has classified this recall as Class II. The recall was initiated voluntarily by the manufacturer.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Syringes
Affected units
56

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: 58002075
  • UDI-DI: 30886158034460
  • Lot/Batch Number: 6074313

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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