Date Initiated by Firm | June 27, 2016 |
Create Date | September 02, 2016 |
Recall Status1 |
Terminated 3 on March 02, 2018 |
Recall Number | Z-2713-2016 |
Recall Event ID |
74706 |
Product Classification |
Arterial blood sampling kit - Product Code CBT
|
Product | The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis. |
Code Information |
Three (3) total lots (lot #884993, lot #903136 & lot #903137). |
Recalling Firm/ Manufacturer |
Cardinal Health 1300 Waukegan Rd Waukegan IL 60085-6724
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For Additional Information Contact | Lindy Schenning 847-362-9303 |
Manufacturer 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. |
FDA Determined Cause 2 | Under Investigation by 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 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. |
Quantity in Commerce | Lot #884993 -16,000 units, Lot #903136 -1,900 units and Lot #903137 - 300 units. |
Distribution | Worldwide Distribution - US (nationwide) and Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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