—#130257

Product

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081412
Affected lot / code info: 1) List Number:11005: Serial Numbers: 18807410 , 18807428 , 18807439 , 18807459 , 18807511 , 18807523 , 18807578 , 16792228 , 16792250

Why it was recalled

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

Root cause (FDA determination)

Component change control

Action the firm took

Hospira sent an Urgent Medical Device Correction letter dated July 2, 2014, to all affected customers. The letter notified customers that Hospira will be contacting them regarding the completion of an audible alarm test and will replace any alarm assemblies that fail to audible alarm test. Additionally, the letter included instructions for customers to: 1) inform potential users of this notification; 2) complete and return the attached reply form; and, 3) if the products were further distributed, notify those accounts of this recall and ask them to contact Stericycle at 888-912-7350 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. A second URGENT MEDICAL DEVICE CORRECTION letter dated July 16, 2014 was sent to all customers of record because the initial letters may have contained errors in the attached data files listing the potentially affected devices at the customer's' facility. The instructions to the customer were unchanged from the original letter. For questions regarding this recall call 800-441-4100.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

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.

Timeline

Recall initiated: 2014-07-02
Posted by FDA: 2015-02-23
Terminated: 2017-05-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130257. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.