Recalls / —
—#43018
Product
Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
- FDA product code
- MEA — Pump, Infusion, Pca
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K022203, K043256
- Affected lot / code info
- List numbers 12384-04, software version 4.08 and 4.09
Why it was recalled
Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
Root cause (FDA determination)
Other
Action the firm took
Field corrections initiated November 2, 2005. The firm has sent notification letters to consignees via Federal Express.
Recalling firm
- Firm
- Hospira Inc
- Address
- 755 Jarvis Dr, Morgan Hill, California 95037-2810
Distribution
- Distribution pattern
- Nationwide. Distributed to 544 domestic consignees, all direct users.
Timeline
- Recall initiated
- 2005-11-02
- Posted by FDA
- 2006-03-09
- Terminated
- 2006-08-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #43018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.