Recall Z-2346-2012— Hospira, Inc.

Name: FDA recall Z-2346-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-02

Class II · Terminated

Class II FDA medical device recall by Hospira, Inc., initiated 2012-08-02, terminated 2014-05-08. It names one FDA 510(k) clearance: K043256. Product: 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 Hospira infusion device.. Reason: Reports of leaking during filling and administration..

Recalling firm: Hospira, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-02
Terminated: 2014-05-08
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03Hospira, Inc.·cleared 2004-12-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 Hospira infusion device.

Reason for recall

Reports of leaking during filling and administration.

Data sourced from openFDA. This site is unofficial and independent of the FDA.