510(k) K982159 ยท FRN Pump, Infusion
ABBOTT PLUM A+ INFUSION PUMP
| Applicant | Abbott Laboratories, North Chicago IL, US |
| Decision | Substantially Equivalent, Jan 12, 1999 |
| Received | Jun 19, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene- Terminated |
FRN | None listed |
| Apr 21, 2014 | Hospira Inc. LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette.
For administration of blood and blood bags for use Terminated |
FRN | None listed |
| Nov 14, 2013 | Hospira Inc. Plum A+ Infusion Pump;
List Number: 11973;
Product Usage:
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general 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 |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 M Terminated |
FPA | None listed |
| Sep 9, 2013 | Hospira Inc. *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 I Terminated |
FPA | 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 7, 2012 | Hospira 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 |
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 |
| 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 |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.