Z-1074-2015 Class I Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-1074-2015 was initiated by Hospira Inc. on Jul 2, 2014 and is designated Class I. Reason for recall: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. The recall status is terminated (terminated May 24, 2017). Affected quantity: 9 infusion pumps.

Recall Details

Product Type
Devices
Report Date
Mar 4, 2015
Initiation Date
Jul 2, 2014
Termination Date
May 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9 infusion pumps

Product Description

The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.

Reason for Recall

One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.

Distribution Pattern

Worldwide Distribution - USA including AK, AL, AR, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Brazil, Canada, Colombia, Ecuador, France, Israel, Italy, Mexico, Oman, Peru, Saudi Arabia, Spain, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Code Information

1) List Number:11005: Serial Numbers: 18807410 , 18807428 , 18807439 , 18807459 , 18807511 , 18807523 , 18807578 , 16792228 , 16792250

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1074-2015
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.