Retiro De Equipo (Recall) de Device Recall Arterial Blood Gas (ABG) Sampling Kit

Recall

74706

Class 2

Z-2713-2016

2016-06-27

Terminated

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148260

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.

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.