Smiths Medical Portex Pulsator Kit Mislabeling Recall
Smiths Medical recalls Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes due to mislabeling. Check labels for incorrect firm name or lot numbers 3306404, 3314069, 3318698.
Lower-risk recall
The product was mislabeled with the incorrect label.
Contact the company
What happened, in plain English
Smiths Medical is recalling a specific blood sampling kit because it was mislabeled with the wrong firm name on the label. This could lead to confusion about the product's origin and potentially affect medical use. Read more at govinfonow.com/recall/70604-smiths-medical-portex-pulsator-kit-mislabeling-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/70604-smiths-medical-portex-pulsator-kit-mislabeling-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3196-2018
Cite this page
“Smiths Medical Portex Pulsator Kit Mislabeling Recall.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70604-smiths-medical-portex-pulsator-kit-mislabeling-recall. Based on FDA recall #Z-3196-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3196-2018%22&limit=1).
Why it’s dangerous
The kit was mislabeled with the incorrect firm name on the label. This could cause confusion about the product's origin and potentially lead to incorrect usage or handling. However, the mislabeling does not pose a direct safety risk during normal medical use.
Who’s affected
Healthcare professionals using the Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes (REF 4080P-2) are likely affected. Patients using this kit under medical supervision are at minimal risk due to the mislabeling issue.
How to tell if you have this one
Check the label for the firm name 'Smiths Medical ASD, Inc.' and lot numbers 3306404, 3314069, or 3318698. The product is sterile and intended for use in medical settings.
- Brand
Smiths Medical- Category
Medical device
What to do — step by step
Check Label
Verify the firm name on the label is 'Smiths Medical ASD, Inc.' and check for lot numbers 3306404, 3314069, or 3318698.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
FDA distribution: “US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Massachusetts, Michigan, New Jersey, New York, North Carolina, Rhode Island, Texas, Utah, Washington.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3196-2018 (July 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3196-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.