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Companies / Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
FDA Regulatory Profile
Summary
- Total Recalls
- 18 (13 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0157-2018 | Class II | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manu | September 5, 2017 |
| D-0158-2018 | Class II | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manuf | September 5, 2017 |
| D-0160-2018 | Class II | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manu | September 5, 2017 |
| D-0159-2018 | Class II | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manu | September 5, 2017 |
| Z-0718-2019 | Class I | Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ | September 5, 2017 |
| Z-0713-2019 | Class I | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | September 5, 2017 |
| Z-0712-2019 | Class I | Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | September 5, 2017 |
| Z-0721-2019 | Class I | Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ | September 5, 2017 |
| Z-0714-2019 | Class I | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ | September 5, 2017 |
| Z-0722-2019 | Class I | Medline Prefilled 550 ml Sterile¿¿ ¿ | September 5, 2017 |
| Z-0715-2019 | Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ | September 5, 2017 |
| Z-0720-2019 | Class I | Portex Unit Dose 15 ml Normal Saline ¿ | September 5, 2017 |
| Z-0711-2019 | Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ | September 5, 2017 |
| Z-0716-2019 | Class I | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | September 5, 2017 |
| Z-0719-2019 | Class I | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | September 5, 2017 |
| Z-0717-2019 | Class I | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ | September 5, 2017 |
| Z-0710-2019 | Class I | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | September 5, 2017 |
| Z-0490-2019 | Class II | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | September 5, 2017 |