FDA (Devices) recall action 64542

ICU recalled 9 products on 2017-07-19

The FDA (Devices) publishes a recall like this one as 9 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 9 pages.

Products: 9
Announced: 2017-07-19
Critical: 0
Units: 596,267

Why these products were recalled

A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.

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.

1–9 of 9

HighFDA (Devices)··2017-07-19
ICU Recalls 71 Plum A+ Infusion Systems Due to Battery Error
ICU is recalling 71 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
ICU is recalling Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
ICU is recalling 21,703 Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Recalls Plum A+ Infusion Systems Due to Battery-Related Therapy Interruption
ICU is recalling 10,609 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Recalls Plum A+ Infusion Systems Due to Battery Error
ICU is recalling 7,351 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Recalls 214 Plum A+ Infusion Systems Due to Battery Error
ICU is recalling 214 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Recalls 180 Plum A+ Infusion Systems Due to Battery Issues
ICU is recalling 180 Plum A+ Infusion Systems because battery issues may cause an E321 error code and interrupt therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
ICU is recalling 363,892 Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting patient therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states
HighFDA (Devices)··2017-07-19
ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption
ICU is recalling 7,848 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient therapy.
Product
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are availabl
Category
Distribution
0 states