The Recall Desk
ModerateFDA (Devices)·Z-2930-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

BVI CustomEyes Procedure Packs are being recalled because they contain Sol-M manufactured syringes that are subject to a voluntary recall.

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: Voluntary precautionary recall of a Class II medical device (syringes) with no reported illnesses or injuries. The specific hazard is not detailed in the source text.

Plain-English summary

BVI CustomEyes Procedure Packs (Part Number 58001970) containing low dead space and Luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M) are being recalled. The packs were distributed nationwide in the United States. A total of 30 units were affected by this recall.

These procedure packs are being recalled due to a voluntary recall of the Sol-M syringes they contain. The specific hazard or defect associated with these syringes is not detailed in the available information.

Healthcare facilities and eye care professionals who received these procedure packs should be aware of this recall. The recalled product is identified by Part Number 58001970, Lot/Batch Number 6074016, and UDI-DI 30886158033760. For further information or instructions regarding this recall, contact the manufacturer or healthcare provider.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001970;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • syringe-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: 58001970
  • UDI-DI: 30886158033760
  • Lot/Batch Number: 6074016

Distribution

Distributed nationwide across the United States.