ClearanceBrief
510(k) K141789 ยท FRN Pump, Infusion

PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE

ApplicantHospira, Inc., Lake Forest IL, US
DecisionSubstantially Equivalent, Jan 16, 2015
ReceivedJul 2, 2014
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K141789

DateFirm and productCodeLinked 510(k)
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
FRNNone listed
Aug 9, 2024ICU Medical Inc
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de
Open, Classified
FRNNone listed
Aug 18, 2023ICU Medical Inc
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 30010
Open, Classified
FRNNone listed
May 16, 2023ICU Medical Inc
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Open, Classified
FRNNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tu
Terminated
MRZNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure L
Terminated
FRNNone listed
Jul 29, 2019ICU Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 M
Terminated
MRZNone listed
Jun 15, 2017ICU Medical Inc
Plum 360 Infusion System
Terminated
FRNNone listed
Dec 30, 2016Hospira Inc., A Pfizer Company
Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
Terminated
FRNNone listed
Mar 25, 2016Hospira Inc.
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad
Terminated
FRNNone listed
Mar 25, 2016Hospira Inc.
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, seco
Terminated
FRNNone listed

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