FDA recall Z-2734-2020

Smiths Medical ASD Inc. · Class I · device

Product

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Reason for recall

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2020-06-26
Report date: 2020-08-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2734-2020