BEUDAMED
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    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    Amico E-Cylinder Canister Holder, distributed by Stryker Communications, Flower Mound, TX 75028. Canister holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code BRY·May 19, 2009

    BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code BRY·August 13, 2007

    Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 0682000863, 06820001009, 0682001010, 0682001076, 0682000864, 0682000857, 0682000858, 0682001077, 0682000865, 0682001011, 0682001078, 0682000866, 0682001012, 0682001080, 0682000867, 0682000959, 0682001079, 0682000850, 0682000851, 0682000852, 0682001269, 0682001567, 0682001569, 0682001570, 06820012691, 06820015671, 06820015691, & 0680015701. The ceiling suspensions are available in different configurations; they can hold monitors (flat panel suspensions), cameras (navigation suspensions arms) or surgical lights. The flat panel could have fixed or adjustable monitor yokes and may be single or dual arm configuration. Each ceiling suspension could hold a maximum of two surgical lights and either one camera or one monitor. There may be multiple ceiling/boom suspensions in an operating room. Intended for use as ceiling-mounted devices for supporting or positioning surgical lights, cameras, and/or monitors.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code BRY·April 15, 2010

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code BRY·January 15, 2016

    CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code BRY·March 27, 2015

    SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256 and the Arm part number in the kit is P17087 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San Diego, CA. The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia providers and automates verification of patient usage records, documents waste, manages inventory levels and tracks utilization.

    FDA Recall
    Terminated ·Cardinal Health Manufacturing LLC·Product code BRY·December 24, 2008

    Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code BRY·April 7, 2010

    Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.

    FDA Recall
    Terminated ·CareFusion Corporation·Product code BRY·November 20, 2009

    Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.

    FDA Recall
    Terminated ·MCKESSON TECHNOLOGIES INC·Product code BRY·July 22, 2013

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 28, 2019

    ARIES System and ARIES M1 System

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·May 24, 2017

    ARIES System and ARIES M1 System

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·April 19, 2017

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·June 29, 2018