The Recall Desk
ModerateFDA (Devices)·Z-2915-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are being voluntarily recalled. The affected packs contain low dead space and luer slip tip 1ml syringes from Sol-Millennium Medical, Inc.

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 recall with voluntary, precautionary nature. No reported illnesses, injuries, or deaths in the source material. The source does not specify the particular defect associated with the recalled syringes.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes have been voluntarily recalled. The procedure packs contain low dead space and luer slip tip 1ml syringes (Part Number 58001809, Lot Number 6071159) manufactured by Sol-Millennium Medical (Sol-M), Inc.

The affected procedure packs were distributed nationwide in the United States.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001809;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-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: 58001809
  • UDI-DI: 30886158032787
  • Lot/Batch Number: 6071159

Distribution

Distributed nationwide across the United States.