510(k) K042081 ยท FRN Pump, Infusion
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Aug 24, 2004 |
| Received | Aug 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042081
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2024 | ICU 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 |
FRN | None listed |
| Aug 9, 2024 | ICU Medical Inc Plum 360/A+ spare batteries. Item Number: SUB0000864. Open, Classified |
FRN | None listed |
| May 16, 2023 | ICU 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 |
FRN | None listed |
| Feb 23, 2015 | Hospira 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 |
FRN | None listed |
| Feb 4, 2015 | Hospira Inc. Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and Terminated |
FRN | None listed |
| Nov 14, 2013 | Hospira Inc. *** 1) Plum A+ Infusion Pump;
List Number: 20678;
Labeled in part: PLUM A+3; for use with Hospira MedNet;
*** 2) Plum A+ Infusion Pump;
List Number: 20679;
Labeled in part: PLUM A+; for use w Terminated |
FRN | None listed |
| Nov 14, 2013 | Hospira Inc. The Plum A+3 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+3 I Terminated |
FRN | None listed |
| Nov 14, 2013 | Hospira 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 |
FRN | None listed |
| Dec 31, 2012 | Hospira 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 |
FRN | None listed |
| Dec 31, 2012 | Hospira Inc. 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 ve Terminated |
FRN | None listed |
| Dec 7, 2012 | Hospira Inc. Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet soft Terminated |
FRN | None listed |
| Oct 4, 2011 | Hospira 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 |
FRN | None listed |
| Oct 4, 2011 | Hospira Inc. 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 ve Terminated |
FRN | None listed |
| Sep 29, 2011 | Hospira 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 |
FRN | None listed |
| Sep 29, 2011 | Hospira Inc. 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 Terminated |
FRN | None listed |
| Mar 14, 2011 | Hospira 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 |
FRN | None listed |
| Mar 14, 2011 | Hospira Inc. 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 Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Plum A+3 Infusion System with Hospira Mednet, list # 20678-04-01, 20678-04-03, 20678-04-51, 20678-04-77, 20678-04-81, 20678-04-05, 20678-04-53; AC cord manufactured by Electri-Cord, Westfield PA, Infu Terminated |
FRN | None listed |
| Oct 6, 2009 | Hospira Inc Plum A+ Infusion System with Hospira Mednet, list #s 20679-04-01, 20679-04-03, 20679-04-05, 20679-04-51, 20679-04-77, 20679-04-79, 20679-04-81, 20792-04-01, 20792-04-03, 20792-04-05, 20792-04-51, 2079 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.