FDA Device recall Z-0318-2022
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 27…
- FDA Device
- Class II
- terminated
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 27… by Magnolia Medical Technologies, citing due to an uptick of complaints associated with premature needle retraction of blood collection system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0318-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-02 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Magnolia Medical Technologies |
| Distribution | US |
Product
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck
Reason
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
Identifiers
| code_info | Model Number/Part Number/Description: 2700-21-EN/P00157-001/Steripath Gen2 Blood Collection System - 21G, Wide Neck UDI…Model Number/Part Number/Description: 2700-21-EN/P00157-001/Steripath Gen2 Blood Collection System - 21G, Wide Neck UDI Sales Pack: 10858366007013 UDI Sterile Pack: 00858366007016 Lot Numbers: 9447412 9447043 9446903 9447120 9446991 9447413 2700-23-EN/P00158-001/Steripath Gen2 Blood Collection System - 23G, Wide Neck UDI Sales Pack: 10858366007020 UDI Sterile Pack: 00858366007023 Lot Numbers: 9446807 9447124 5005432 9446708 9447121 27BD-21-EN/P00166-000/Steripath Gen2 Blood Collection System - 21G, Long Neck UDI Sales Pack: 10858366007037 UDI Sterile Pack: 00858366007030 Lot Numbers: 5005328 9446696 9446547 9446994 27BD-23-EN/P00167-000/Steripath Gen2 Blood Collection System - 23G, Long Neck UDI Sales Pack: 10858366007044 UDI Sterile Pack: 00858366007047 Lot Numbers: 9447122 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.