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    HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·September 1, 2010

    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

    FDA Recall
    Terminated ·Airways Development LLC·Product code BYE·September 24, 2015

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000 501, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.

    FDA Recall
    Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

    Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.

    FDA Recall
    Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, REF 137 001 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.

    FDA Recall
    Terminated ·Westmed, Inc.·Product code BYE·January 15, 2019

    Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000 138 000, Manufacturer: Ambu International A/S, DK2750 Ballerup USA: Ambu Inc. (Ambu USA) Linthicum, MD 21090-1356 USA, Made in Denmark

    FDA Recall
    Terminated ·Ambu Incorporated·Product code BYE·August 21, 2007

    Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BYE·March 4, 2008

    Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code BYE·March 4, 2008

    Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-000-11. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-53. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, 0.512" wide, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

    Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009