The Recall Desk
ModerateFDA (Devices)·Z-2806-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-M syringes subject to a separate voluntary recall.

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: The recall is classified as FDA Class II and is a voluntary precautionary measure driven by a component recall, with no specific injuries or illnesses reported in the source text.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs, Part Number 58000404. The recall is initiated because these procedure packs contain low dead space syringes and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These specific Sol-M syringes are the subject of a separate voluntary recall.

The affected product consists of 40 units of BVI CustomEyes Procedure Packs. The specific lot number is 6073569, and the UDI-DI is 30886158018385. The products were distributed nationwide in the United States.

Healthcare facilities and consumers should stop using the affected BVI CustomEyes Procedure Packs and contact the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000404;
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: 58000404
  • UDI-DI: 30886158018385
  • Lot/Batch Number: 6073569

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 →

Same manufacturer · Beaver Visitec International, Inc.

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