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Medtronic Perfusion Systems recalls Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Recalled June 23, 2021 · FDA recall Z-1880-2021 · Medtronic Perfusion Systems
Hazard
Specific lots may have been manufactured with insufficient or incomplete welds. · FDA Class II
Units
12 tubing packs
Sold at
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Description
Specific lots may have been manufactured with insufficient or incomplete welds.
Product
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →