The Recall Desk
ModerateFDA (Devices)·Z-2925-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs recalled due to incorrect syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical instead of the intended product. The recall involves 57 units 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 medical device voluntary recall with no reported illnesses or injuries. The issue is a product inclusion defect—incorrect syringes included in the packs—rather than a demonstrated safety hazard, making it a moderate-level precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001933) because some packs contain syringes manufactured by Sol-Millennium Medical, Inc. instead of the intended product. The affected syringes are low dead space syringes and Luer slip tip syringes.

The recall involves approximately 57 units of affected Procedure Packs (Lot Number 6073549) that were distributed nationwide. The product can be identified by UDI-DI: 30886158033555. This is a voluntary recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • device-defect

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: 58001933
  • UDI-DI: 30886158033555
  • Lot/Batch Number: 6073549

Distribution

Distributed nationwide across the United States.