BEUDAMED
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    Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization of items intended for immediate use. Prevacuum designed for fast, efficient sterilization of porous, heat- and moisture-stabile materials, in addition to the same sterilization capabilities as a Gravity sterilizer.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·October 22, 2019

    Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry

    FDA Recall
    Terminated ·Skytron, Div. The KMW Group, Inc·Product code FLE·April 18, 2019

    Midmark M7 UltraClave and Ritter M7 SpeedClave, Tabletop Steam Sterilizers.

    FDA Recall
    Terminated ·Midmark Corp·Product code FLE·March 5, 2003

    FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.

    FDA Recall
    Terminated ·Fort Defiance Industries, LLC·Product code FLE·May 24, 2018

    Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).

    FDA Recall
    Terminated ·Steris Corp·Product code FLE·March 22, 2007

    Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities.

    FDA Recall
    Terminated ·Steris Corp·Product code FLE·March 6, 2008

    ATLAS Loading Car

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·December 26, 2018

    The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components: -Loading Car: Shelving unit which holds the items to be sterilized; and the -Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate. Product Usage: The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·March 23, 2012

    AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·February 12, 2013

    Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·October 22, 2019

    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 621103

    FDA Recall
    Open, Classified ·Scican Ltd.·Product code FLE·June 22, 2023

    AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·February 19, 2015

    AMSCO 400 and AMSCO C Small Steam Sterilizers

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·September 3, 2015

    P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

    FDA Recall
    Open, Classified ·Fort Defiance Industries, LLC·Product code FLE·August 19, 2021

    AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·October 18, 2013

    Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterilize reusable equipment that is heat and moisture stable.

    FDA Recall
    Terminated ·Midmark Corportation·Product code FLE·October 24, 2011

    STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303

    FDA Recall
    Open, Classified ·Scican Ltd.·Product code FLE·June 22, 2023

    MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE SF MG; PUMP MMT-1884XC 780G V6.5 CLIN US MG; PUMP MMT-1885XC 780G V6.5 CLIN MM; PUMP MMT-1886XC 780G V6.5 CLIN MG; PUMP MMT-1885L MM780G 6.5V BLE MMOL; PUMP MMT-1886L MM780G 6.5W BLE MG; KIT MMT-1896ES MM780G V6.5W MG; KIT MMT-1896WWA MM780G BLE MG ES; KIT MMT-1895WWA MM780G BLE MMOL AR; KIT MMT-1895WWA MM780G BLE MMOL CS; KIT MMT-1895WWA MM780G BLE MMOL DA; KIT MMT-1895WWA MM780G BLE MMOL DE; KIT MMT-1895WWA MM780G BLE MMOL EN; KIT MMT-1895WWA MM780G BLE MMOL FI; KIT MMT-1895WWA MM780G BLE MMOL FR; KIT MMT-1895WWA MM780G BLE MMOL IT; KIT MMT-1895WWA MM780G BLE MMOL NL; KIT MMT-1895WWA MM780G BLE MMOL NO; KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV; KIT MMT-1895WWA MM780G BLE MMOL HU; KIT MMT-1896WWA MM780G BLE MG AR; KIT MMT-1896WWA MM780G BLE MG DE; KIT MMT-1896WWA MM780G BLE MG EL; KIT MMT-1896WWA MM780G BLE MG HE; KIT MMT-1896WWA MM780G BLE MG IT; KIT MMT-1896WWA MM780G BLE MG PL; KIT MMT-1896WWA MM780G BLE MG RO; KIT MMT-1896WWA MM780G BLE MG TR; KIT MMT-1896WWA MM780G BLE MG NL; KIT MMT-1896WWA MM780G BLE MG FR; KIT MMT-1896WWA MM780G BLE MG ES;

    FDA Recall
    Open, Classified ·Medtronic Minimed·Product code OZP·March 15, 2021

    First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109

    FDA Recall
    Terminated ·First Aid Only Inc·Product code LRR·December 10, 2007

    Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code NIK·August 16, 2023