U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Arterial blood sampling kit - Product Code CBT
원인
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.
조치
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.