Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Recalled August 12, 2020 · FDA recall Z-2734-2020 · Smiths Medical ASD

Hazard

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

Units

35616 units

Sold at

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

Description

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

Product

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

Manufacturer(s)

Smiths Medical ASD Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →