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U.S. Department of Health and Human Services

Class 2 Device Recall Pyxis

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 Class 2 Recall
Pyxis
see related information
Date Posted March 28, 2013
Recall Status1 Terminated on March 28, 2013
Recall Number Z-1015-2013
Recall Event ID 53991
Product Classification Cabinet, Table And Tray, Anesthesia - Product Code BRY
Product Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
Code Information All Pyxis Anesthesia System Model 2000
Recalling Firm/
Manufacturer
CareFusion Corporation
10020 Pacific Mesa Blvd
San Diego, California 92121
Manufacturer Reason
for Recall
The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
FDA Determined
Cause 2
DESIGN: Device Design
Action Carefusion sent a Safety Alert Notification letter dated January 13, 2010 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to ensure back-up procedures were in place in case of system down-time or lock-up, including review of the back-up procedures with staff. The letter included an update to the PAS 2000 User Guide. The letterstates that a CareFusion field representative will be contacting customers to make arrangements to apply warning labels to the PAS 2000 electronics doors. Customers were instructed to complete and return the Response Card included. For questions contact your local field support representative ot the Advocacy department at customer.advocacy@carefusion.com.
Quantity in Commerce 2637
Distribution Worldwide Distribution - USA (Nationwide) including CANADA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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