BEUDAMED
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    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code OIE·April 17, 2014

    Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·June 27, 2012

    Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code MXM·May 21, 2012

    Endoscopic Introducer/Extractor

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 21, 2017

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-012, IMPLANT SIZE 12, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-010, IMPLANT SIZE 10, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-009, IMPLANT SIZE 9, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-011, IMPLANT SIZE 11 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-004, IMPLANT SIZE 4 , Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No:7850-5-003, IMPLANT SIZE 3,Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-007, IMPLANT SIZE 7, Howmedica, Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-002 ,IMPLANT SIZE 2 ,Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007

    CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA

    FDA Recall
    Terminated ·Abbott Laboratories·Product code gkz·June 8, 2009

    CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa Clara, CA

    FDA Recall
    Terminated ·Abbott Laboratories·Product code gkz·June 8, 2009

    CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA

    FDA Recall
    Terminated ·Abbott Laboratories·Product code gkz·June 8, 2009

    Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.

    FDA Enforcement
    Class II ·Terminated·Beevers Manufacturing & Supply, Inc.·December 10, 2014