Recalls / —
—#148260
Product
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
- FDA product code
- CBT — Arterial Blood Sampling Kit
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Three (3) total lots (lot #884993, lot #903136 & lot #903137).
Why it was recalled
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.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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 GMB-GLB-ALFieldActions@CareFusion.com 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.
Recalling firm
- Firm
- Cardinal Health
- Address
- 1300 Waukegan Rd, Waukegan, Illinois 60085-6724
Distribution
- Distribution pattern
- Worldwide Distribution - US (nationwide) and Canada.
Timeline
- Recall initiated
- 2016-06-27
- Terminated
- 2018-03-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #148260. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.