Z-3196-2018Class III

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2...

Name: Z-3196-2018 Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2...
Creator: Smiths Medical ASD Inc.
Published: 2018-07-13
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-07-13 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2018-07-13. FDA classified it as Class III and gives the reason as "The product was mislabeled with the incorrect label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3196-2018
Classification: Class III
Status: Terminated
Initiated: 2018-07-13
Posted: 2018-09-19
Terminated: 2018-10-19
Recalling firm: Abbott Medical
Product: 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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The product was mislabeled with the incorrect label.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Recall notifications dated 7/13/2018 were issued via FedEx overnight mail on 7/13/2018 explaining the reason for recall, risk to health, and instructing the customer to check their inventory for the affected lot numbers.
Quantity in commerce: 29,600 kits
Distribution: US Nationwide Distribution in the states of CT, MA, MI, NC, NJ, NY, RI, TX, UT, and WA.
Product codes and lots: Lot numbers 3306404, 3314069, and 3318698.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3196-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3196-2018	Class III	Terminated	Voluntary: Firm initiated	2018-09-26	2018-09-18

Product code JKA

K981035Class IIPro-Vent, Pulsator Arterial Blood Sampling SyringesSims Portex, Inc. / cleared 1998-04-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)