FDA recall Z-2393-2021

Magnolia Medical Technologies, Inc. · Class II · device

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 for recall

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

Key facts

Status
Terminated
Initiation date
2021-08-02
Report date
2021-09-08
Termination date
2023-02-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Seattle, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2393-2021