FDA (Devices) recall action 64263

Hospira Inc. recalled 8 products on 2013-11-20

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2013-11-20
Critical: 0
Units: 223,347

Why these products were recalled

Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira Inc. is recalling 182,971 Plum A+ Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
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+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Distribution
52 states
HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+ Infusers Due to Broken Pressure Sensor Pin
Hospira Inc. is recalling 179 Plum A+ Hyperbaric Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
The Plum A+ Hyperbaric 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+ Hyperbaric Infusion System is designed to deliver parenteral, enteral, o
Category
Distribution
52 states
HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 7,692 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
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 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Distribution
52 states
HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Pressure Sensor Pin
Hospira is recalling 214 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
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 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Distribution
52 states
HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Pressure Sensor Pin
Hospira is recalling 10,669 Plum A+ Infusion Systems because the distal pressure sensor pin may break. This defect can prevent the device from detecting occlusions in the administration set.
Product
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+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Distribution
52 states
HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 71 Plum A+ Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
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+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Distribution
52 states
HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk
Hospira is recalling 21,551 Plum A+3 Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
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 Infusion System is designed to deliver parenteral, enteral, or epidural infusions
Category
Distribution
52 states
HighFDA (Devices)··2013-11-20
Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk
Hospira Inc. is recalling Plum A+ Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.
Product
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+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions o
Category
Distribution
52 states