Z-2713-2016 Class II Terminated
FDA device recall Z-2713-2016 was initiated by Cardinal Health on Jun 27, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 2, 2018). Affected quantity: Lot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 7, 2016
- Initiation Date
- Jun 27, 2016
- Termination Date
- Mar 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Lot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units.
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) and Canada.
Code Information
Three (3) total lots (lot #884993, lot #903136 & lot #903137).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2713-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026