Recall Z-0490-2019 ยท FQH Lavage, Jet
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
| Date | Sep 5, 2017 |
| Status | Terminated |
| Reason | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| Root cause | Other |
| Action | Firm sent recall notification letters to customers on 9/5/2017. |
| Quantity | 10,440 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080779 | IRRISEPT WOUND CLEANSING SYSTEM Irrimax Corporation, Feb 4, 2009 |