The Recall Desk
ModerateFDA (Devices)·Z-2900-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

Beaver Visitec International is recalling 627 units of BVI CustomEyes Procedure Packs due to included Sol-M syringes subject to voluntary manufacturer 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: FDA Class II voluntary precautionary recall with no reported illnesses or injuries and no specific hazard articulated in the source. This is a manufacturer-initiated recall.

Plain-English summary

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes are the subject of a voluntary recall initiated by Beaver Visitec International. The syringes are manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected product has part number 58001691 and lot number 6063240.

A total of 627 units were distributed nationwide. The recall was classified by the FDA as Class II. For additional information, visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2900-2024.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001691;
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: 58001691
  • UDI-DI: 30886158032107
  • Lot/Batch Number: 6063240

Distribution

Distributed nationwide across the United States.