Recall Z-0318-2022— Magnolia Medical Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Magnolia Medical Technologies, Inc., initiated 2021-11-02, terminated 2023-05-08. It names one FDA 510(k) clearance: K192247. 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..
- Recalling firm
- Magnolia Medical Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-02
- Terminated
- 2023-05-08
- Firm location
- Seattle, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.