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U.S. Department of Health and Human Services

Class 2 Device Recall Pyrxis Anesthesia System 3500

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 Class 2 Device Recall Pyrxis Anesthesia System 3500see related information
Date Initiated by FirmAugust 13, 2007
Date PostedSeptember 26, 2007
Recall Status1 Terminated 3 on March 28, 2012
Recall NumberZ-0555-2007
Recall Event ID 39378
Product Classification ANESTHESIA MEDICATION STATION - Product Code BRY
ProductPyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA
Code Information All serial numbers of the Pyxis Anesthesia Station, Model 3500
Recalling Firm/
Manufacturer		 Cardinal Health 303 Inc DBA Alaris Products
10221 Wateridge Cir
San Diego CA 92121-2733
For Additional Information ContactStacy L. Lewis
858-458-7830
Manufacturer Reason
for Recall		System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.
FDA Determined
Cause 2		Other
ActionThe field action consisted of phone calls and a mailing conducted to all customers for the Pyxis Anesthesia System 3500 beginning on 08/13/2007. The customers will be notified by registered return receipt mail by Recall Notifications dated August 14, 2007. Separate letters will be sent to the Director of Pharmacy, Chief of Anesthesia, Director of Risk Management, and Director of Surgery at each facility. Recommended actions will be provided as a short-term fix and a long-term fix of the software will be issued shortly.
Quantity in Commerce369
DistributionNationwide to Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Mississippi, Montana, New Jersey, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, and Wyoming.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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