FDA-Device2021-04-28Class II
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
Smiths Medical ASD Inc.
Hazard
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
Sold states
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
Affected count
400 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1474-2021Don't want to check this manually?
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