FDA recall Z-1872-2021

Medtronic Perfusion Systems · Class II · device

Product

Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.

Reason for recall

Specific lots may have been manufactured with insufficient or incomplete welds.

Distribution

US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.

Key facts

Status
Terminated
Initiation date
2021-04-29
Report date
2021-06-23
Termination date
2023-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2021