FDAFDA · Food and drugs·Recall number Z-3079-2024
Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
Published September 18, 2024 · Recall initiated: May 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sol-Millennium Medical Inc.
- Distributor
- 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
- Lot
- 1) Model No. STCB01, UPC N/A, LOT NUMBERS: 4201063, 4209005, 4307016, 4308061, 4311036; 2) Model No. STCB02, UPC N/A, LOT NUMBERS: 4201064; 3) Model No. 110101150020, UPC N/A LOT NUMBERS: EXPIRED 4) Model No. STCT01, UPC: Sole in Canada only, LOT NUMBERS: 4301023, 4308072, 4308073, 4309043, 4310029, 04311037, 4312011, 4312093, 4402006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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