Z-0205-2014 Class II Terminated
Recalled by Hospira Inc.
— Lake Forest, IL
FDA device recall Z-0205-2014 was initiated by Hospira Inc. on Feb 5, 2012 and is designated Class II. 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… The recall status is terminated (terminated Nov 14, 2016). Affected quantity: List No. 11973: 71 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2013
- Initiation Date
- Feb 5, 2012
- Termination Date
- Nov 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- List No. 11973: 71 units
Product Description
Plum A+ Infusion Pump; List Number: 11973; 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
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
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.
Code Information
List No. 11973; Serial Numbers: 12570148 , 12570150 , 12570154 , 12570163 , 12570170 , 12570177 , 12570204 , 12570211 , 12570212 , 12570255 , 12570270 , 12570319 , 12570359 , 12570385 , 12570413 , 12570425 , 12570455 , 12570487 , 12570662 , 12570695 , 12570854 , 12570915 , 12571080 , 12571243 , 12571437 , 12571631 , 12571692 , 12571776 , 12571826 , 12571835 , 12571837 , 12571842 , 12571877 , 12571880 , 12571886 , 12572317 , 12572369 , 12572586 , 12572909 , 12573547 , 12573567 , 12573837 , 12573990 , 12574424 , 12574501 , 12574524 , 12574556 , 12574599 , 12574619 , 12574731 , 12574749 , 12574853 , 12574858 , 12574860 , 12574865 , 12574961 , 12575626 , 12575698 , 12575886 , 12576125 , 12576443 , 12576485 , 12576518 , 12576593 , 12576609 , 12576710 , 12576722 , 12577271 , 12577685 , 12578856 , 12579183
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0205-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.