Sol-Millennium Medical Inc.: Device Recall

Recall Details

Recall Number

Z-3074-2024

Classification

Class II

Product Type

Device

Recalling Firm

Sol-Millennium Medical Inc.

Status

Ongoing

Date Initiated

05/09/2024

Location

Chicago, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Reason for Recall

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

Product Description

Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

Distribution Pattern

US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama

Other Recalls by Sol-Millennium Medical Inc.

• Class II: Risk 05/09/2024
  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
• Class II: Risk 05/09/2024
  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
• Class II: Risk 05/09/2024
  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
• Class II: Risk 05/09/2024
  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
• Class II: Risk 05/09/2024
  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

View all recalls by Sol-Millennium Medical Inc. →