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

FDA device recall Z-0555-2007 · posted 2007-09-26 · Terminated

Recall details

Recalling firm

Cardinal Health 303 Inc DBA Alaris Products

Reason for recall

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

Action taken

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

Status

Terminated

Product code

BRY

Quantity affected

369

Distribution

Nationwide to Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Mississippi, Montana, New Jersey, Ohio, Oklahoma, Pennsylvania, Rhod

Date initiated

2007-08-13

Date posted

2007-09-26

Date terminated

2012-03-28

Location

San Diego, CA