ClearanceBrief
510(k) K070398 ยท FRN Pump, Infusion

HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391

ApplicantHospira, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Apr 24, 2007
ReceivedFeb 12, 2007
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K070398

DateFirm and productCodeLinked 510(k)
Aug 9, 2024ICU Medical Inc
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS un
Open, Classified
FRNNone listed
Aug 9, 2024ICU Medical Inc
Plum 360/A+ spare batteries. Item Number: SUB0000864.
Open, Classified
FRNNone listed
May 16, 2023ICU Medical Inc
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 1197
Open, Classified
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Jul 7, 2017ICU
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps a
Terminated
FRNNone listed
Feb 23, 2015Hospira Inc.
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 t
Terminated
FRNNone listed
Nov 14, 2013Hospira Inc.
Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general
Terminated
FRNNone listed
Nov 14, 2013Hospira Inc.
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Inf
Terminated
FRNNone listed
Dec 31, 2012Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391
Terminated
FRNNone listed
Dec 7, 2012Hospira Inc.
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 li
Terminated
FRNNone listed
Oct 4, 2011Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 -
Terminated
FRNNone listed
Sep 29, 2011Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 1239
Terminated
FRNNone listed
Mar 14, 2011Hospira Inc.
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391
Terminated
FRNNone listed
Oct 6, 2009Hospira Inc
Plum A+ v.11.X, list #s 12391-04-01, 12391-04-03, 12391-04-05, 12391-04-11, 12391-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
Terminated
FRNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.