The Recall Desk
ModerateFDA (Devices)·Z-2807-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., due to a voluntary recall of those syringes. The recall affects 154 units 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 medical device recall with voluntary status. No illnesses or injuries are reported in the source, and the specific nature of the defect is not detailed.

Plain-English summary

Beaver Visitec International (BVI) is recalling BVI CustomEyes Procedure Packs (Part Number 58000426) because they contain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M), which Sol-M has voluntarily recalled. The affected syringes are low dead space luer lock and luer slip 1ml syringes.

The recall affects approximately 154 units distributed nationwide in the United States. The affected lot number is 6069170, and the product is identified by UDI-DI 30886158019894.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000426;
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: 58000426
  • UDI-DI: 30886158019894
  • Lot/Batch Number: 6069170

Distribution

Distributed nationwide across the United States.