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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 221–240 of 1,000 recalls

Class ITerminated

Alaris System PC Unit Model 8000 modular infusion pump and monitoring system

CareFusion 303, Inc.

If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power loss may result in an interruption of patient therapy or monitoring.

June 30, 2020 · DeviceView details →
Class ITerminated

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

Baxter Healthcare Corporation

Baxter is updating the device IFU for safety communication regarding cleaning practices.

June 30, 2020 · DeviceView details →
Class ITerminated

Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

CareFusion 303, Inc.

Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring.

June 30, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset, REF: A120-161XPS

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset With Female Luer, REF: A120-160XPSN

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset, REF: A120-160X2YB

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard BodySet, REF: A120-160SAS

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset, REF: A120-160XSFK

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

CMExpress Microbore Sets, REF: A120-161C

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard set with Female Luer, REF: A120-003XSN

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset with Filter, REF: A120-160XSFE

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset, REF: A120-161XPSV

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset, REF: A120-161XYBS

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset, REF: A100-163XSL

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

Standard BodySet with Needleless Connectors, REF: A120-125XS

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset with Filter, REF: A100-164XESF

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
Class ITerminated

BodyGuard Microset, REF: A100-163XE90S

CME America, LLC

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

June 16, 2020 · DeviceView details →
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