The Recall Desk
ModerateFDA (Devices)·Z-2790-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled Voluntarily

BVI CustomEyes Procedure Packs containing low dead space and luer slip syringes from Sol-Millennium Medical are being voluntarily recalled.

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 recall explicitly described as voluntary with no reported illnesses, injuries, or hospitalization cited in the source material. Per the severity rubric, voluntary precautionary recalls are classified as Moderate.

Plain-English summary

BVI CustomEyes Procedure Packs are the subject of a recall due to the inclusion of syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected packs contain low dead space and luer slip tip syringes that are part of a voluntary recall.

The recalled procedure packs were distributed nationwide in the United States. The recall involves 230 units with Lot Number 6055965 and Part Number 584727. The product can be identified using UDI-DI: 30886158008096.

Healthcare providers and consumers who have received these procedure packs should discontinue use and contact Beaver Visitec International, Inc., the recalling firm, for further information regarding the recall and available remedies.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584727;
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: 584727
  • UDI-DI: 30886158008096
  • Lot/Batch Number: 6055965

Distribution

Distributed nationwide across the United States.