The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS
FDA device recall Z-2027-2014 · posted 2014-07-10 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of "nanog/kg/min" or "milliUnits/min" on an unmatched medication will produce a
- Action taken
- Hospira sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 6, 2014 was sent to all affected customers. The letter included instructions for customers to: notify all potential users in their organization of the recall, and to complete and return the attached reply form. The letter further notified customers that they will be contacted by a member of Hospira's Clinical Services Team to make arrangements to review the drug library and implement the appropriate mitigation. Hospira will further work with the direct account to ensure Auto Programming installations receive Pharmacy consulting to support the implementation of the mitigation and that a correction for this issue will be addressed in a future version of the software. Reports of adverse events or product complaints can be made by contacting Hospira Global Complaint Management at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or via e-mail at ProductComplaintsPP@hospira.com. Additional information or technical assistance can be obtained by contacting the Hospira Advanced Knowledge Center at 800-241-4002, option 4 (24 hours a day, 7 days a week).
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 13 units
- Distribution
- US Nationwide in the states of FL, LA, PA, WA, WY and the country of Hong Kong
- Date initiated
- 2014-06-06
- Date posted
- 2014-07-10
- Date terminated
- 2016-12-06
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE (K042609) | Hospira, Inc. | 2004-10-06 |