FDA recall Z-2735-2020

Product

Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

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-2735-2020