FDA recall Z-2662-2018

Product

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Reason for recall

Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

Distribution

US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.

Key facts

Status

Terminated

Initiation date

2018-04-13

Report date

2018-08-15

Termination date

2023-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2662-2018