Recall Z-3079-2024— Sol-Millennium Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by Sol-Millennium Medical Inc., initiated 2024-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Sol-Millennium Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-09
- Firm location
- Chicago, IL, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.