Recall Z-1517-2015— Hospira Inc.

Name: FDA recall Z-1517-2015
Creator: U.S. Food and Drug Administration
Published: 2013-02-27

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-02-27, terminated 2016-11-07. It names one FDA 510(k) clearance: K043256. Product: The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.. Reason: The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-27
Terminated: 2016-11-07
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

The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.

Reason for recall

The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.

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