Recall Z-2393-2021— Magnolia Medical Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by Magnolia Medical Technologies, Inc., initiated 2021-08-02, terminated 2023-02-22. It names one FDA 510(k) clearance: K192247. Product: 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.. Reason: Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU)..
- Recalling firm
- Magnolia Medical Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-02
- Terminated
- 2023-02-22
- 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
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.
Reason for recall
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.