Recall Z-1518-2015— Hospira Inc.
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: K042800. Product: The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication 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 recordK-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 LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication 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.