Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
FDA device recall Z-0601-06 · posted 2006-03-09 · Terminated
Recall details
- Recalling firm
- Hospira Inc
- Reason for recall
- Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
- Action taken
- Field corrections initiated November 2, 2005. The firm has sent notification letters to consignees via Federal Express.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEA
- Quantity affected
- 10,489 units
- Distribution
- Nationwide. Distributed to 544 domestic consignees, all direct users.
- Date initiated
- 2005-11-02
- Date posted
- 2006-03-09
- Date terminated
- 2006-08-11
- Location
- Morgan Hill, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256) | Hospira, Inc. | 2004-12-06 |
| ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 (K022203) | Abbott Laboratories | 2002-08-01 |