CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Sterile Eyewash (sterile isotonic phosphate buffered saline recalled
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical is recalling Sterile Eyewash (sterile isotonic phosphate buffered saline solution) per, distributed in Iowa, Wisconsin. The recall was initiated on 5 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0160-2018
- FDA event ID
- 78369
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical, Vernon Hills, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2017
- FDA classified
- 5 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
Timeline
| 5 Sep 2017 | Recall initiated by company | |
| 5 Jan 2018 | Classified by FDA | +122 days |
| 17 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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, USA 60061. Model Number: 32-005587
Where it was distributed
IA, WI
Questions about this recall
Why was it recalled?
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Which lots are affected?
Lot: A257, EXP 05-20-2018; A258, EXP 05-19-2018; B017, EXP 01-12-2019; B116, B119, EXP 05-03-2019; B120, EXP 05-04-2019; B131, EXP 05-05-2019; Z535, EXP 10-13-2017; Z638, EXP 12-19-2017.
Where was it sold?
IA, WI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 78369This product is part of a recall event; the main page for the event is Sterile Eyewash (sterile isotonic phosphate buffered saline recalled.
More recalls from Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Portex Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Portex Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Portex Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Portex Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |
| Device | CLASS I | Intermed Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ recalled | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical | Sterility | Nationwide |