Seattle, WA, United States
Magnolia Medical Technologies, Inc. recalls
2 recalls recorded since 2018, most recently on 2 November 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 2 November 2021
- Terminated
- 8 May 2023
- Reason
- Due to an uptick of complaints associated with premature needle retraction of blood collection system.
- Distribution
- U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0318-2022
- 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-
Terminated Class II Medical devices
- Recall started
- 2 August 2021
- Terminated
- 22 February 2023
- Reason
- Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
- Distribution
- U.S. Nationwide distribution i the states of AL, CO, FL, GA, IL, IN, MD, MI, NE, NY, PA, SC, TX, VA, WV, and WY. O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2393-2021
- Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.