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Terminated

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

FDA Recall Z-2713-2016 · Posted None

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeCBT
Date Initiated2016-06-27
Date Terminated2018-03-02
Product QuantityLot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units.

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US (nationwide) and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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