CLASS I Device recall · Reported 13 Feb 2019 · FDA Enforcement Report
Portex Normal Saline 9%) Unit Dose¿¿¿¿ ¿ recalled
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical is recalling Portex Normal Saline 9%) Unit Dose¿¿¿¿ ¿, distributed nationwide in the US. The recall was initiated on 5 Sep 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0721-2019
- FDA event ID
- 81021
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical, Vernon Hills, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Sep 2017
- FDA classified
- 4 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 5 Sep 2017 | Recall initiated by company | |
| 4 Feb 2019 | Classified by FDA | +517 days |
| 13 Feb 2019 | Published in enforcement report | +9 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
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Is Portex Normal Saline 9%) Unit Dose¿¿¿¿ ¿ recalled?
Yes. Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical recalled Portex Normal Saline 9%) Unit Dose¿¿¿¿ ¿ on 5 Sep 2017. The recall is Class I and its status is Terminated. Recall number Z-0721-2019.
Why was it recalled?
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Which lots are affected?
Model # UD9005 Lot Number: ¿B515
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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