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Medtronic Perfusion Systems recalls Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Recalled June 23, 2021 · FDA recall Z-1874-2021 · Medtronic Perfusion Systems
Hazard
Specific lots may have been manufactured with insufficient or incomplete welds. · FDA Class II
Units
15 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 BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →