Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Arterial Blood Gas (ABG) Sampling Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Arterial Blood Gas (ABG) Sampling Kit see related information
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
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
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.
-
-