FDA recall Z-1487-2021

Product

Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.

Reason for recall

Potentially defective component in the AC power adapter which may fail over time.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, FL, IA, IN, LA, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NY, OH, PA, RI, SC, TN, TX and the country of Puerto Rico.

Key facts

Status

Terminated

Initiation date

2021-03-19

Report date

2021-05-05

Termination date

2022-07-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medina, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1487-2021