Vernon Hills, IL, United States
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalls
3 recalls recorded since 2018, most recently on 5 September 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)1
Terminated Class II Drugs
- Recall started
- 5 September 2017
- Terminated
- 19 December 2018
- Reason
- Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Distribution
- IA, WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0158-2018, D-0160-2018, D-0159-2018, D-0157-2018
- Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois,
- Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois,
- Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois,
- Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois,
Terminated Class II Medical devices
- Recall started
- 5 September 2017
- Terminated
- 23 September 2024
- Reason
- Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Distribution
- 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, PR, SC, TN, TX, UT, VA, VT, WA, and WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0490-2019
- Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Terminated Class I Medical devices
- Recall started
- 5 September 2017
- Terminated
- 16 April 2024
- Reason
- 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, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0721-2019, Z-0715-2019, Z-0718-2019, Z-0714-2019, Z-0717-2019, Z-0719-2019, Z-0720-2019, Z-0722-2019, Z-0716-2019, Z-0711-2019, Z-0710-2019, Z-0713-2019 and 1 more
- Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
- Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
- Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
- Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
- Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
- Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
- Portex Unit Dose 15 ml Normal Saline ¿
- Medline Prefilled 550 ml Sterile¿¿ ¿
- and 5 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.