318 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604.
FDA Recall
Terminated
·Medtronic Inc·Product code KRI·December 14, 2009
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The Backplate/Holder is designed to allow the user to move the port support location to accommodate different tubing circuit designs to permit mounting flexibility.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KRI·October 2, 2009
Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code KRI·August 12, 2011
Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model numbers: 99120-01
FDA Recall
Terminated
·Abbott Laboratories·Product code KRY·September 18, 2006
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The gas cylinder holder serves to hold an oxygen cylinder in aircraft.
FDA Recall
Terminated
·Maquet Cardiopulmonary Ag Kehler Strasse 31 Rastatt Germany·Product code KRI·April 4, 2018
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code KRI·March 1, 2011
IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
FDA Recall
Terminated
·Medtronic Inc·Product code KRI·December 14, 2009
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code KRI·June 18, 2020
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
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
FDA Recall
Terminated
·Luminex Corporation·Product code OOI·April 16, 2021
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
FDA Recall
Terminated
·Catheter Research, Inc·Product code HGS·April 7, 2015
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
FDA Recall
Terminated
·Luminex Corporation·Product code OOI·November 17, 2021
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LLZ·May 1, 2011
Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LLZ·April 6, 2010
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
ARIES System and ARIES M1 System
FDA Enforcement
Class II
·Terminated·Luminex Corporation·May 24, 2017
ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio, Inc. 3400 Hunter's Way, Charlottesville, VA 22911 www.origio.com The Cryopette (r) is a cryopreservative storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
FDA Recall
Terminated
·ORIGIO HUMAGEN PIPETS INC.·Product code MQK·November 28, 2011
GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code IYO·October 22, 2009
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Recall
Terminated
·Iris Diagnostics·Product code JJW·September 18, 2012