ARGYLE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A DEVICE WAS RECEIVED FOR EVALUATION, AND THE REPORTED CONDITION WAS NOT OBSERVED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED AIR/OXYGEN IN THE LINE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THEY DID NOT OBSERVE ANY CRACKS, HOLES OR BREAKS IN THE LINE. THERE WAS NO HARM REPORTED.

Additional Manufacturer Narrative

SECTION D4 (MODEL NUMBER AND CATALOG NUMBER): ORIGINALLY REPORTED AS 8888160531 AND SHOULD BE 8888160333; (UNIQUE IDENTIFIER (UDI) #): ORIGINALLY REPORTED AS (B)(4) AND SHOULD BE (B)(4). SECTION D3 (MANUFACTURER NAME): ORIGINALLY REPORTED AS CARDINAL HEALTH, INC. AND SHOULD BE CARDINAL HEALTH 200, LLC.