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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet Software; List Number: 20792; Labeled in part: PLUM A+; for use with Hospira MedNet; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
Recall Number Z-0209-2014
Classification Class II
Code Info Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the <a href="http://www.fda.gov/Safety/Recalls/EnforcementReports/UCM376115" target="_blank">Addendum to Enforcement Report</a>.
Product Distributed Qty 1) List No. 20678: 21,551 units; 2) List No. 20679: 7,737 units; 3) List No. 20792: 126,696 units
Reason For Recall Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira has identified the following design attributes of the pressure sensor that may cause the calibration to drift sooner than expected: strain gage protective layers' moisture resistance issues, pressure assembly chassis residual structural stress issues, and relaxation of clamping force from mounting screws for strain gage and pin stack.

Event Detail

Event Id 64091
Product Type Devices
Status Ongoing
Recalling Firm Hospira Inc.
City Lake Forest
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-02-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.