Sol-Millennium Medical Inc.: Device Recall

Recall Details

Recall Number

Z-3078-2024

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 Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only

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. →