CLASS III Device recall · Reported 26 Sep 2018 · FDA Enforcement Report

Portex Pulsator Arterial Blood Sampling Kit recalled

Smiths Medical ASD is recalling Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and, distributed nationwide in the US. The recall was initiated on 13 Jul 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot numbers 3306404, 3314069, and 3318698.

Quantity recalled29,600 kits

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-3196-2018
FDA event ID: 80632
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class III
Status: Terminated
Recall initiated: 13 Jul 2018
FDA classified: 18 Sep 2018
Reported: 26 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

13 Jul 2018	Recall initiated by company
18 Sep 2018	Classified by FDA	+67 days
26 Sep 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The product was mislabeled with the incorrect label.

Product as listed by the FDA

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

Where it was distributed

US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.

Nationwide Connecticut Massachusetts Michigan North Carolina New Jersey New York Rhode Island Texas Utah Washington

Questions about this recall

Why was it recalled?

The product was mislabeled with the incorrect label.

Which lots are affected?

Lot numbers 3306404, 3314069, and 3318698.

Where was it sold?

US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

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