Recall Z-3077-2024— 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: Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;. 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
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;
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.