Recall Z-0481-2013— Hospira Inc.

Name: FDA recall Z-0481-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-26

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2012-10-26, terminated 2016-11-14. It names 5 FDA 510(k) clearances: K070398, K052052, K031185 and 2 more. Product: Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care. Reason: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-26
Terminated: 2016-11-14
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

5 on FDA's record

K070398 — HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391Hospira, Inc.·cleared 2007-04-24
K052052 — HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5Hospira, Inc.·cleared 2005-08-24
K031185 — ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULEAbbott Laboratories·cleared 2003-04-30
K011442 — ABBOTT PLUM A+INFUSION PUMP, MODEL 11971Abbott Laboratories·cleared 2001-06-05
K982159 — ABBOTT PLUM A+ INFUSION PUMPAbbott Laboratories·cleared 1999-01-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680 Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care

Reason for recall

The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.

Data sourced from openFDA. This site is unofficial and independent of the FDA.