21

Oct

2009

Cl Il Pyxis Anesthesia System 3500

0

Company:Cardinal Health Manufacturing, LLC, .
Date of Enforcement Report 10/21/2009
Class:ll

PRODUCT
Pyxis Anesthesia System 3500, The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia providers and automates verification of patient usage records, documents waste, manages inventory levels and tracks utilization. Recall # Z-1883-2009

REASON
Cardinal Health has sent out a Safety Alert Notification to inform its customers that the SR2b Software for the Pyxis Anesthesia System 3500 (PAS 3500) has received several customer reports of system “non-responsiveness” (lock ups) during the use of the product since its release in September 2008.

RECALLING FIRM/MANUFACTURER
Cardinal Health Manufacturing, LLC, San Diego, CA, by letter on December 17, 2008. Firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
250 units

DISTRIBUTION
Nationwide and GErmany

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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