Device Recall AMPLATZER Delivery Systems

  • Modelo / Serial
    M01J08-12, M02D26-01, M02L11-20, M03A09-12, M03B20-12, M03D16-24, M03F18-08, M03L12-09, M04C23-09, M04G01-24
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA

12 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    M01K01-6, M02C12-24, M02C25-15, M02F05-23, M02F24-05, M02L02-21, M03A09-10, M03A09-15, M03A20-10, M03B20-17 M03C24-14, M03F02-17, M03G23-08, M03H12-42, M03J19-07 M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14 M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23 M04H03-23, M04J17-07, M04K07-02
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • Modelo / Serial
    M02D26-02, M02I23-02, M02J10-09, M02K07-47, M03C04-06 M03D16-16, M03F18-07, M03K14-07, M03L18-50, M03M03-11 M04C23-10, M04E24-18, M04G01-20
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • Modelo / Serial
    M01J19-12, M02B14-10, M02C12-27, M02D16-19, M02D16-23 M02F24-07, M02G23-04, M02H19-05, M02K07-48, M02K12-10 M02L11-13, M03A09-13, M03A20-11, M03A20-18, M03A22-12 M03B10-56, M03B20-11, M03C24-13, M03D08-08, M03D16-18 M03E27-08, M03F13-07, M03F18-10, M03H12-43, M03J04-12 M03J19-08, M03J25-27, M03K09-23, M03K28-36, M03L11-46 M03M03-12, M03M29-07, M04A19-28, M04A28-16, M04B03-13 M04B09-19, M04B17-33, M04B24-08, M04C23-11, M04D06-13 M04D26-06, M04D26-10, M04F08-22, M04F28-47, M04H24-22 M04J07-09, M04J10-22, M04J17-08, M04K15-10, M04L02-02
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • Modelo / Serial
    M01L17-02, M02A28-21, M02A28-24, M02K07-46, M03G10-30,  M03L18-52, M04B09-18, M04C23-13, M04E27-20, M04F08-24,  M04H03-20, M04K26-18
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
  • Modelo / Serial
    M01K01-7, M01K28-18, M02C25-24, M02D16-17, M02D16-21,  M02E16-28, M02F05-22, M02F24-08, M02G23-01, M02G23-06,  M02K07-51, M02K12-09, M02K20-06, M02K25-13, M02L02-29,  M02L11-10, M02L11-15, M02L11-17, M03A09-70, M03A27-34,  M03A27-35, M03B10-52, M03B10-55, M03B20-19, M03C13-11,  M03C13-13M03C24-11, M03G09-13, M03G24-19, M03G30-26,  M03H01-02, M03H05-17, M03H05-18, M03H12-40, M03H15-03,  M03H15-05, M03H15-09, M03J02-16, M03J10-08, M03J10-09,  M03K14-08, M03K24-15, M03K28-37, M03M02-12, M03M03-08,  M03M29-03, M03M29-06, M03M30-13, M04A19-29, M04A28-18,  M04B03-12, M04B17-38, M04C08-13, M04C15-04, M04C15-06,  M04D06-09, M04D13-17, M04D20-08, M04D26-07, M04D26-09,  M04E24-19, M04E27-24, M04F21-43, M04F23-23, M04G27-25,  M04H12-12, M04H24-20, M04L05-08
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
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