The Recall Desk
ModerateFDA (Devices)·Z-2878-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs With Recalled Sol-M Syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, which are subject to a voluntary recall. 37 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 an FDA Class II voluntary recall with no reported illnesses or injuries. The recall is precautionary in nature, as the source does not articulate a specific safety incident or hazard.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). The recalled syringes include low dead space and luer slip tip models, which are the subject of a voluntary recall by Sol-M.

The affected procedure packs were distributed nationwide in the United States. A total of 37 units have been identified in this recall. The affected product is identified by Part Number 58001511, UDI-DI 30886158024232, and Lot Number 6060235.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001511;
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: 58001511
  • UDI-DI: 30886158024232
  • Lot/Batch Number: 6060235

Distribution

Distributed nationwide across the United States.