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Medtronic Perfusion Systems recalls Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Recalled June 23, 2021 · FDA recall Z-1895-2021 · Medtronic Perfusion Systems
Hazard
Specific lots may have been manufactured with insufficient or incomplete welds. · FDA Class II
Units
7 tubing sets
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 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →