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
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Jan 16, 2015 |
| Received | Jul 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | ICU Medical, Inc. IV Sets with drip chambers Open, Classified |
FRN | None listed |
| Aug 9, 2024 | ICU 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 |
FRN | None listed |
| Aug 18, 2023 | ICU 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 |
FRN | None listed |
| May 16, 2023 | ICU Medical Inc Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 Open, Classified |
FRN | None listed |
| Jul 29, 2019 | ICU 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 |
MRZ | None listed |
| Jul 29, 2019 | ICU 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 |
FRN | None listed |
| Jul 29, 2019 | ICU 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 |
MRZ | None listed |
| Jun 15, 2017 | ICU Medical Inc Plum 360 Infusion System Terminated |
FRN | None listed |
| Dec 30, 2016 | Hospira 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 |
FRN | None listed |
| Mar 25, 2016 | Hospira 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 |
FRN | None listed |
| Mar 25, 2016 | Hospira 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 |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.