BEUDAMED
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    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·January 22, 2009

    LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·January 22, 2009

    SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.

    FDA Recall
    Terminated ·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·January 8, 2009

    SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.

    FDA Recall
    Terminated ·Hsmg, Inc. D/b/a Smartinfuser Usa·Product code MEB·January 8, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37 Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·December 18, 2009

    Elekta Leksell Stereotactic System, used for localization (spatial reference) for cranial surgery using X-ray or CT and MRI Image data.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code HAW·October 2, 2009

    IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code LXH·January 22, 2009

    Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, inc.·Product code GJS·July 22, 2009

    Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, inc.·Product code GJS·July 22, 2009

    Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001. CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, inc.·Product code GJS·July 22, 2009

    Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003. Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge beneath new or existing fixed prosthetic restorations.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LYC·January 22, 2009

    Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code MNI·February 2, 2010

    Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115.

    FDA Recall
    Terminated ·Centurion Medical Products·Product code BTR·September 22, 2009

    Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes.

    FDA Recall
    Terminated ·Centurion Medical Products·Product code BTR·September 22, 2009

    Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code DKB·April 22, 2009