FDA Device recall Z-3077-2024
Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551 by Sol Millennium Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3077-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-09 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sol Millennium Medical |
| Distribution | US |
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.
Identifiers
| upc | 810018098605 |
|---|---|
| upc | 810018098698 |
| code_info | 1) Model No. P180010ET, Lot Numbers: 4209010; 2) Model No. P180020ET, Lot Numbers: 4209011; 3) Model No. P180060ET, Lot Numbers: 4209009, 4209011; |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3077-2024%22
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