Device product
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
Z-2713-2016
Product summary
- Firm
- Cardinal Health
- Event
- Event 74706
- Status
- Terminated
- Classification
- Class II
- Quantity
- Lot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units.
- Official record key
device-enforcement:Z-2713-2016
Official wording
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.
Code information: Three (3) total lots (lot #884993, lot #903136 & lot #903137).
Distribution pattern: Worldwide Distribution - US (nationwide) and Canada.
Derived failure modes
-
Unknown
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.