Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA

FDA Recall Z-0555-2007 · Posted 2007-09-26

Recalling FirmCardinal Health 303 Inc DBA Alaris Products
Recall StatusTerminated
Product CodeBRY
Date Initiated2007-08-13
Date Terminated2012-03-28
Product Quantity369

Reason for Recall

System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.

Firm Action

The 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.

Root Cause

Other

Distribution Pattern

Nationwide 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑