Recall Z-0625-2013— Hospira Inc.

Name: FDA recall Z-0625-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-07

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2012-12-07, terminated 2016-11-14. It names 3 FDA 510(k) clearances: K052052, K042081, K021350. Product: Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system 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 door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-12-07
Terminated: 2016-11-14
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

3 on FDA's record

K052052 — HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5Hospira, Inc.·cleared 2005-08-24
K042081 — PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREHospira, Inc.·cleared 2004-08-24
K021350 — ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348Abbott Laboratories·cleared 2002-05-14

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+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system 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 door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.

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