The Recall Desk
ModerateFDA (Devices)·Z-2795-2024·Announced 2024-09-04

Procedure packs with Sol-Millennium syringes subject to voluntary recall

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled. Approximately 198 units were 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: FDA Class II voluntary precautionary recall. The source does not specify a hazard or report any illnesses or injuries, consistent with Level 2 (Moderate) severity for precautionary voluntary recalls.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) Luer Lock and Luer Slip 1ml syringes (Part Number 58000056) are being voluntarily recalled. The syringe components are manufactured by Sol-Millennium Medical, Inc.

Approximately 198 units were distributed nationwide. The affected products were manufactured under lot/batch numbers 6065306 and 6069372, with UDI-DI 30886158008980.

Patients and healthcare facilities using affected procedure packs should contact Beaver Visitec International, Inc. for further instructions and return procedures.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000056;
Manufacturer
Beaver Visitec International, Inc.

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 (4)

  • Part Number: 58000056
  • UDI-DI: 30886158008980
  • Lot/Batch Number: 6065306
  • 6069372

Distribution

Distributed nationwide across the United States.