The Recall Desk
HighFDA (Devices)·Z-2839-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Recall

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes that are subject to a manufacturer recall. A total of 103 units were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with no reported illnesses. Voluntary recall of syringes for eye procedures indicates a defect requiring corrective action in a high-risk product category, though the specific hazard is not detailed in the source.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs. These procedure packs contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). Sol-M has initiated a voluntary recall of these syringes, which prompted Beaver Visitec International to recall their affected CustomEyes Procedure Packs.

The affected syringes are identified by Part Number 58001025 and Lot Number 6064450. A total of 103 units of the affected BVI CustomEyes Procedure Packs are included in this recall.

The recalled procedure packs have been distributed nationwide across the United States.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001025;
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: 58001025
  • UDI-DI: 30886158021637
  • Lot/Batch Number: 6064450

Distribution

Distributed nationwide across the United States.