Z-1028-2015Class III

Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes...

Name: Z-1028-2015 Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes...
Creator: Smiths Medical ASD, Inc.
Published: 2014-12-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-12-17 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial... on 2014-12-17. FDA classified it as Class III and gives the reason as "The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1028-2015
Classification: Class III
Status: Terminated
Initiated: 2014-12-17
Posted: 2015-01-29
Terminated: 2015-06-25
Recalling firm: Abbott Medical
Product: Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Smiths Medical notified American Medical Depot via telephone on 12 December 2014. Smiths Medical instructed them to put product at their location on hold. American Medical Depots customer will be instructed to return their unused product for replacement.
Quantity in commerce: 900 units
Distribution: US in the state of FL.
Product codes and lots: Lot Number: 2782094

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1028-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1028-2015	Class III	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-28

Product code JKA

K952516Class IIPro-Vent, Line Draw, PulsatorSmiths Industries Medical Systems, Inc. / cleared 1995-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)