65 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure
FDA Recall
Terminated
·Edwards Lifesciences Research Medical, Inc.·Product code DXC·November 26, 2008
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code JJW·April 20, 2020
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code LRO·November 16, 2018
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code PQZ·April 20, 2020
GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults.
FDA Recall
Terminated
·Cardinal Health, Inc·Product code EWO·September 16, 2008
Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins.
FDA Recall
Terminated
·Cardinal Health, Inc·Product code IYN·January 6, 2009
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
FDA Recall
Terminated
·Cardinal Health Inc.·Product code JIN·April 20, 2020
Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins.
FDA Recall
Terminated
·Cardinal Health, Inc·Product code IYN·January 6, 2009
Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient. Large Port Specimen Sock, used to convert the pour/accessory port of a Cardinal Suction canister into a specimen retainer. The sock is used as an accessory in a suction collection system. Its placed in a suction canister to remove solids from the liquid aspirated during surgery. The solids may consist of patient tissue that are then sent to pathology or retained for other purposes. There is no direct contact between this device and the patient.
FDA Recall
Terminated
·Cardinal Health Inc·Product code NNI·February 18, 2011
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·January 16, 2019
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·May 27, 2020
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·May 27, 2020
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·May 27, 2020
The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.
FDA Recall
Terminated
·Scion Cardio-Vascular, Inc.·Product code FGO·June 30, 2003
Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447.
FDA Recall
Terminated
·Cardinal Health 203, Inc·Product code CBK·February 22, 2008
Replacement Kit, Power PCBA with Memory PCBA. REF 14425. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
FDA Recall
Terminated
·Cardinal Health 203, Inc·Product code CBK·February 22, 2008
The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings.
FDA Recall
Terminated
·Cardinal Health 203, Inc·Product code CBK·September 8, 2004
SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
FDA Recall
Terminated
·Scion Cardio-Vascular, Inc.·Product code FGO·May 23, 2003
Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447, USA.
FDA Recall
Terminated
·Cardinal Health 203, Inc·Product code CBK·February 22, 2008
Viasys healthcare, Pulmonetic Systems LTV 950 Ventilator The ventilator is suitable for use in institutional, home or transport settings. Fully self-contained ventilator in a compact and lightweight design. It can operate from an internal battery, external battery or AC power. Applications include long term acute care or short term / recovery room. Pulmonetic Systems, 17400 Medina Rd., Suite 100, Minneapolis, MN 55447.
FDA Recall
Terminated
·Cardinal Health 203, Inc·Product code CBK·February 22, 2008