The Recall Desk
ModerateFDA (Devices)·Z-2894-2024·Announced 2024-09-04

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

Beaver Visitec International is recalling 84 units of 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 source text describes a voluntary recall of a medical device component without reporting any illnesses, injuries, or specific FDA Class I/II classification for this specific BVI recall, fitting the criteria for a voluntary precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling 84 units of BVI CustomEyes Procedure Packs, Part Number 58001631. These procedure packs contain Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc.

The recall is being conducted because the Sol-M syringes included in these packs are subject to a separate voluntary recall for low dead space syringes and luer slip tip syringes. The affected units were distributed nationwide in the United States.

Healthcare facilities and consumers should stop using these specific procedure packs and contact the recalling firm for further instructions or a replacement.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001631;
Affected units
84

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: 58001631
  • UDI-DI: 30886158031780
  • Lot/Batch Number: 6061721

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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