Recall Z-0714-2019
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company · initiated September 5, 2017
Class I – dangerous or defective products that could cause serious health problems or death
Product
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.
Codes / lots: Model # 0352IMJ Lot Numbers: ¿A457, A597, B157, B236, Z589, Z655, Z656, and Z661
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
FDA-determined cause: Process control
Action taken
Firm sent recall notification letters to customers on 9/5/2017.
Details
- Recall number
- Z-0714-2019
- Initiated
- September 5, 2017
- Posted by FDA
- February 4, 2019
- Terminated
- April 16, 2024
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Quantity
- 128,000 sold to Japan only
- 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, Germany, Greece, Italy, Japan, and Switzerland.
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, Vernon Hills, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0710-2019 Class I | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0711-2019 Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0712-2019 Class I | Portex 1000 ml Sterile Water USP Pour BottleLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0713-2019 Class I | Portex 500 ml Sterile Water USP Pour BottleLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0715-2019 Class I | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0716-2019 Class I | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0717-2019 Class I | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0718-2019 Class I | Medline Prefilled 350 ml SterileLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0719-2019 Class I | Portex Unit Dose 5 ml Normal Saline (0.9%)Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0720-2019 Class I | Portex Unit Dose 15 ml Normal SalineLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0721-2019 Class I | Portex 5ml Normal Saline (0.9%) Unit DoseLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |
| Z-0722-2019 Class I | Medline Prefilled 550 ml SterileLack of sterility assurance: leaking containers which could lead to exposure to infectious agents. | 09/05/2017Terminated |