510(k) K043256 ยท MEA Pump, Infusion, Pca
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Dec 6, 2004 |
| Received | Nov 24, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043256
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2015 | Hospira Inc. The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits. Terminated |
MEA | None listed |
| Mar 8, 2013 | Hospira Inc. The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, crit Terminated |
MEA | None listed |
| Sep 10, 2012 | Hospira, Inc. Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045.
For use with a compatible Hospira PCA pump set with injector and a compatible Hos Terminated |
MEA | None listed |
| Mar 9, 2006 | Hospira Inc Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09 Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.