The Recall Desk
ModerateFDA (Devices)·Z-2939-2024·Announced 2024-09-04

Beaver Visitec CustomEyes Procedure Packs with Sol-M Syringes Recalled

Beaver Visitec International is recalling CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip syringes due to a voluntary recall by the syringe manufacturer, 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: This is an FDA Class II medical device recall initiated voluntarily by the syringe manufacturer with no reported adverse events mentioned in the source. The rubric classifies voluntary precautionary recalls without reported harm as Moderate severity.

Plain-English summary

Beaver Visitec International, Inc. is recalling CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58002080, UDI-DI: 30886158034514). The affected lot is 6074317. These procedure packs each contain 25 units and were distributed nationwide throughout the United States.

The syringes are manufactured by Sol-Millennium Medical (Sol-M), Inc. and are the subject of a voluntary recall initiated by the syringe manufacturer.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002080;
Manufacturer
Beaver Visitec International, Inc.

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: 58002080
  • UDI-DI: 30886158034514
  • Lot/Batch Number: 6074317

Distribution

Distributed nationwide across the United States.