The Recall Desk
ModerateFDA (Devices)·Z-2802-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs: Voluntary Recall of Sol-Millennium Medical Syringes

BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. Approximately 43 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: This is a Class II voluntary, precautionary recall with no reported illnesses or injuries mentioned in the source. The source does not detail a specific hazard, indicating this is a preventive measure rather than a response to documented harm.

Plain-English summary

BVI CustomEyes Procedure Packs containing specific syringe models manufactured by Sol-Millennium Medical (Sol-M), Inc. are subject to a voluntary recall. The affected packs contain Part Number 58000266, which includes low dead space and luer slip tip 1ml syringes.

Approximately 43 units of the affected procedure packs were distributed nationwide in the United States. The recalled packs are identified by Lot Number 6073117 and UDI-DI 30886158009901.

Customers and healthcare facilities that received the recalled procedure packs should discontinue their use and contact Beaver Visitec International, Inc. for further instructions regarding replacement or proper handling of the affected products.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000266;
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: 58000266
  • UDI-DI: 30886158009901
  • Lot/Batch Number: 6073117

Distribution

Distributed nationwide across the United States.