Food, drugs, devices › Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Device recall: Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
FDA enforcement event 81021 is a device recall by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company of Vernon Hills, IL, initiated 5 Sep 2017 and classified Class I, with 13 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 3% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 16 Apr 2024. Initiation: voluntary: firm initiated. Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company has 3 enforcement events on this register, with a median of 4 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, Vernon Hills, IL.
Reason for recall
"Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0710-2019 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | 70,860 | Class I | Terminated | 13 Feb 2019 |
| Z-0711-2019 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ | 57,336 | Class I | Terminated | 13 Feb 2019 |
| Z-0712-2019 | Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | 21,876 | Class I | Terminated | 13 Feb 2019 |
| Z-0713-2019 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ | 9,828 | Class I | Terminated | 13 Feb 2019 |
| Z-0714-2019 | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ | 128,000 sold to Japan only | Class I | Terminated | 13 Feb 2019 |
| Z-0715-2019 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ | 11,508 Canada only | Class I | Terminated | 13 Feb 2019 |
| Z-0716-2019 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ | 16,104 Japan only | Class I | Terminated | 13 Feb 2019 |
| Z-0717-2019 | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ | 16,380 | Class I | Terminated | 13 Feb 2019 |
| Z-0718-2019 | Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ | 235,560 | Class I | Terminated | 13 Feb 2019 |
| Z-0719-2019 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ | 102,000 | Class I | Terminated | 13 Feb 2019 |
| Z-0720-2019 | Portex Unit Dose 15 ml Normal Saline ¿ | 357,552 | Class I | Terminated | 13 Feb 2019 |
| Z-0721-2019 | Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ | 106,000 | Class I | Terminated | 13 Feb 2019 |
| Z-0722-2019 | Medline Prefilled 550 ml Sterile¿¿ ¿ | 54,924 | Class I | Terminated | 13 Feb 2019 |
Context
Other enforcement events for Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Sep 2017 | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Device | Class II | 1 |
| 5 Sep 2017 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Ca | Drug | Class II | 4 |
All 3 events for Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Apr 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.