The Recall Desk
ModerateFDA (Devices)·Z-2834-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing defective Sol-M syringes. The voluntary recall affects products 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 voluntary Class II medical device recall with manufacturing defects in syringes. The source does not report illnesses or injuries, and the precautionary nature of the recall places this in the Moderate category per the severity rubric.

Plain-English summary

Beaver Visitec International, Inc. is voluntarily recalling BVI CustomEyes Procedure Packs (Part Number 58000960) due to defective syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs were distributed nationwide in the United States, with the recall affecting 48 units (Lot Number 6060636).

The recall was initiated because the Sol-M syringes present in these procedure packs were subject to a voluntary recall due to manufacturing defects related to low dead space and luer slip tip design.

Healthcare facilities and medical professionals who have received these procedure packs should discontinue use and contact Beaver Visitec International for instructions on return or replacement of the affected product.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000960;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-defect
  • dead-space-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: 58000960
  • UDI-DI: 30886158022122
  • Lot/Batch Number: 6060636

Distribution

Distributed nationwide across the United States.