The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environme

FDA device recall Z-1071-2015 · posted 2015-02-23 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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.

Root cause

Component change control

Status

Terminated

Product code

FRN

Quantity affected

315 infusion pumps

Distribution

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, T

Date initiated

2014-07-02

Date posted

2015-02-23

Date terminated

2017-05-24

Location

Lake Forest, IL

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