FDA Medical Device Recalls (openFDA)
Hospira Inc: Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
- Recall number
- Z-0601-06
- Recalling firm
- Hospira Inc
- Product
- Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
- Status
- Terminated
- Initiated
- 2005-11-02
- Posted
- 2006-03-09
- Terminated
- 2006-08-11
- Reason
- Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
- Root cause
- Other
- Action
- Field corrections initiated November 2, 2005. The firm has sent notification letters to consignees via Federal Express.
- Quantity
- 10,489 units
- Distribution
- Nationwide. Distributed to 544 domestic consignees, all direct users.
- Lot, serial or model codes
- List numbers 12384-04, software version 4.08 and 4.09
- 510(k) numbers
- ["K022203","K043256"]
- PMA numbers
- not on file
- Product code
- MEA
- Firm FEI
- 2921482
- Firm city
- Morgan Hill
- 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