Recall Z-0721-2019 ยท CAF Nebulizer (Direct Patient Interface)
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Portex 5ml Normal Saline (0.9%) Unit Dose
| Date | Feb 4, 2019 (initiated Sep 5, 2017) |
| Status | Terminated |
| Reason | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| Root cause | Process control |
| Action | Firm sent recall notification letters to customers on 9/5/2017. |
| Quantity | 106,000 |
| 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, Germ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820227 | STER-O-DOSE Inhalation Therapy Equipment, Co., Feb 23, 1982 |