FDA-Device2021-06-23Class II
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, 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
15 tubing packs
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1874-2021Don't want to check this manually?
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