FDA-Device2021-04-28Class II
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
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
3740 devices
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1473-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief