FDA Medical Device Recalls (openFDA)
Cardinal Health 303 Inc DBA Alaris Products: Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA
- Recall number
- Z-0555-2007
- Recalling firm
- Cardinal Health 303 Inc DBA Alaris Products
- Product
- Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA
- Status
- Terminated
- Initiated
- 2007-08-13
- Posted
- 2007-09-26
- Terminated
- 2012-03-28
- Reason
- System lock up; mini-drawers -under certain circumstances during use, are not accessable, delaying the user from accessing critical medications.
- Root cause
- Other
- 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.
- Quantity
- 369
- Distribution
- 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.
- Lot, serial or model codes
- All serial numbers of the Pyxis Anesthesia Station, Model 3500
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BRY
- Firm FEI
- 3003879246
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28