The Recall Desk
ModerateFDA (Devices)·Z-2882-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall by the manufacturer. The procedure packs 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 medical device recall with no reported illnesses or injuries. The recall is voluntary and precautionary in nature, meeting the criteria for a moderate-severity voluntary precautionary recall.

Plain-English summary

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs (Part Number 58001545) that contain Sol-Millennium Medical (Sol-M) manufactured syringes. The affected procedure packs are distributed nationwide in the United States, with 110 units identified in this recall.

Sol-Millennium Medical initiated a voluntary recall of low dead space syringes and luer slip tip syringes that are included in some BVI CustomEyes Procedure Packs. These syringes are used in ophthalmic procedures.

Affected lot and batch numbers are 6062861 and 6064638. Healthcare facilities and medical professionals who have received these procedure packs are advised to review these lot numbers to determine if they have been affected by this recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001545;
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 (4)

  • Part Number: 58001545
  • UDI-DI: 30886158031995
  • Lot/Batch Number: 6062861
  • 6064638

Distribution

Distributed nationwide across the United States.