Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 13, 2019
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company recalled Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ - a critical-severity action.
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ was recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company in February 13, 2019. Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.. Check the official notice for the remedy. Verify recall #Z-0713-2019 with the FDA Devices before acting.
The recall
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company issued this critical-severity FDA Devices recall-Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents..
- Critical
- severity level
- 10K units
- affected scope
- Class I
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0713-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0713-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on September 5, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company is listed as the recalling firm, operating out of Vernon Hills, IL. Federal records list the affected scope as 9,828.
The documented reason for this recall is: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Distribution data in the federal record shows the product reached: 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 cou…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9,828
Related Recalls
6
6 from same agency
Product description
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0713-2019 |
| Date reported | February 13, 2019 |
| Date initiated | September 5, 2017 |
| Recalling firm | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company |
| Firm location | Vernon Hills, IL |
| Affected scope | 9,828 |
| 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0713-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿. Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company. Units affected: 9,828.
Why was this product recalled? ▼
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Critical. Recall number: Z-0713-2019.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0713-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.