FDA recall Z-0716-2019

Product

Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

Reason for recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Distribution

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

Key facts

Status

Terminated

Initiation date

2017-09-05

Report date

2019-02-13

Termination date

2024-04-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2019