The Recall Desk
ModerateFDA (Devices)·Z-2885-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs recalled due to Sol-M syringes

BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled due to a voluntary manufacturer recall of the syringe components included in these procedure packs.

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 precautionary recall initiated by the syringe manufacturer with no reported illnesses or injuries mentioned in the source. While classified as FDA Class II, the absence of reported incidents and the manufacturer-initiated precautionary action result in a Moderate severity score.

Plain-English summary

BVI CustomEyes Procedure Packs have been recalled due to a voluntary manufacturer recall of syringes made by Sol-Millennium Medical (Sol-M), Inc. The affected packs contain Sol-M low dead space syringes and luer slip tip syringes, identified by part number 58001568.

Approximately 45 units of the affected procedure packs were distributed to medical facilities and suppliers throughout the United States. The recalled syringe lot numbers are 6059666 and 6073550. This recall was initiated voluntarily by the syringe manufacturer as a precautionary measure.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568;
Manufacturer
Beaver Visitec International, Inc.
Hazard
  • manufacturing-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: 58001568
  • UDI-DI: 30886158024683
  • Lot/Batch Number: 6059666
  • 6073550

Distribution

Distributed nationwide across the United States.