Portex 5ml Normal Saline (0.9%) Unit Dose
FDA device recall Z-0721-2019 · posted 2019-02-04 · Terminated
Recall details
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Reason for recall
- Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Action taken
- Firm sent recall notification letters to customers on 9/5/2017.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 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, in
- Date initiated
- 2017-09-05
- Date posted
- 2019-02-04
- Date terminated
- 2024-04-16
- Location
- Vernon Hills, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STER-O-DOSE (K820227) | Inhalation Therapy Equipment, Co. | 1982-02-23 |