FDA-Device2021-06-23Class II
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Hazard
Specific lots may have been manufactured with insufficient or incomplete welds.
Sold states
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Affected count
2 tubing packs
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2021Don't want to check this manually?
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