The Recall Desk
ModerateFDA (Devices)·Z-2787-2024·Announced 2024-09-04

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

Beaver Visitec International is recalling 19 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 recall is classified as FDA Class II, but the source text describes it as a voluntary recall driven by a component issue without reporting specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling 19 units of BVI CustomEyes Procedure Packs, Part Number 584630. These specific 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 Sol-M is voluntarily recalling its low dead space syringes and luer slip tip syringes. The BVI CustomEyes Procedure Packs are affected because they include these specific Sol-M syringes as components.

The affected units were distributed nationwide in the United States. The specific lot number for the recalled BVI packs is 6067412. Healthcare providers and consumers should check their inventory for BVI CustomEyes Procedure Packs with Part Number 584630 and Lot Number 6067412 and stop using them if they contain the affected Sol-M syringes.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584630;
Affected units
19

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: 584630
  • UDI-DI: 30886158141557
  • Lot/Batch Number: 6067412

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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