Z-2713-2016Class II

The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas...

Name: Z-2713-2016 The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas...
Creator: Cardinal Health
Published: 2016-06-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-06-27 / Terminated

FDA source

Cardinal Health began a recall of The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis on 2016-06-27. FDA classified it as Class II and gives the reason as "Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2713-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-27
Posted: 2016-09-02
Terminated: 2018-03-02
Recalling firm: Medtronic, Inc.
Product: The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
Product code: CBT Arterial Blood Sampling Kit
Reason for recall: Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the missing locking clasp component.
FDA root cause: Under Investigation by firm
Action: CareFusion/BD sent out a FIELD SAFETY NOTICE of the field correction in writing on June 27, 2016. The letter described the nature of the recall and provided actions to be performed. Carefusion/BD directed customers to take the following actions: Step #1: Inspect current inventory on-hand to identify the presence of the affected Arterial Blood Gas Sampling Kit(s). Step #2: Complete the Customer Response Form by checking all appropriate boxes and providing all accurate information as required. Step #3: Destroy all affected product(s) in-stock in accordance with their facility's destruction protocol. Step #4: Return the Customer Response Form to [email protected] Step #5: If the customers want to obtain credit and/or replacement of destroyed product(s) they are asked to call their CareFusion/BD Customer Support Department at 800.323.9088 (Option #1 ). For any additional questions and support concerning the voluntary Field Safety Corrective Action, customers are asked to call (847)362.9303.
Quantity in commerce: Lot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units.
Distribution: Worldwide Distribution - US (nationwide) and Canada.
Product codes and lots: Three (3) total lots (lot #884993, lot #903136 & lot #903137).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2713-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2713-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-09-01

Product code CBT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)