FDA recall Z-0490-2019

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · Class II · device

Product

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Reason for recall

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

Distribution

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, PR, SC, TN, TX, UT, VA, VT, WA, and WI

Key facts

Status: Terminated
Initiation date: 2017-09-05
Report date: 2018-11-28
Termination date: 2024-09-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2019