Recall Z-2713-2016— Cardinal Health
Class II · Terminated
Class II FDA medical device recall by Cardinal Health, initiated 2016-06-27, terminated 2018-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.. Reason: 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..
- Recalling firm
- Cardinal Health
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-27
- Terminated
- 2018-03-02
- Firm location
- Waukegan, IL, United States
Product description
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.