FDA-Device2021-06-23Class II
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, 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
12 tubing packs
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1880-2021Don't want to check this manually?
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