FDA-Device2020-08-12Class I
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Smiths Medical ASD Inc.
Hazard
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Sold states
Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago
Affected count
35616 units
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2734-2020Don't want to check this manually?
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