Devices

Device Recall Bard

  • Modelo / Serial
    Model # 8F: Enpath Part Number 10775-003, BARD Part Number XD10775003 (Distributed in US and Internationally). 8F Lots #s W34968 (80 units), W35440 (35 units), W35522 (40 units), W35705 (17 units, sent as SAMPLES, labeled NOT FOR HUMAN USE), W35719 (320 units), W35952 (79 units), W37292 (300 units), W37567 (116 units), W38340 (298 units), W38341 (87 units), W38342 (87 units), W38974 (99 units), W38975 (100 units), W39174 (100 units), W40410 (100 units), W40479 (87 units), W40480 (85 units), W40481 (100 units), W40483 (87 units).  Model # 9F: Enpath Part Number 10775-004 (9F), BARD Part Number XD10775004, (Distributed Internationally (EU) only), 9F lot #s; W36392 (3 units), W36623 (5 units), W36884 (2 units), W36974 (8 units).
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, MA
  • Descripción del producto
    Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bard Electrophysiology Division.
  • Manufacturer
    Enpath Medical, Inc.
  • 1 Event

Fabricante

Enpath Medical, Inc.
  • Dirección del fabricante
    Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
  • Source
    USFDA

81 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall BARD DORADO
  • Modelo / Serial
    LOT NUMBERS: 93FT0152
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135712
  • Manufacturer
    Bard Peripheral Vascular Inc
Device Recall BARD DORADO
  • Modelo / Serial
    LOT NUMBERS: 93DT0146, 93DT0175, 93IT0211, 93IT0211
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135715
  • Manufacturer
    Bard Peripheral Vascular Inc
Device Recall Bard PEG
  • Modelo / Serial
    Lots: 43FQA076, 43IQA096, 43KQA098, HURD1299, HURE3445 , HURI0365, HUSA0502, HUSC0154.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • Descripción del producto
    Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" , REF 003028, 28F, Sterile.
  • Manufacturer
    C.R. Bard Access Systems, Inc
Device Recall Bard Deluxe Guidewire PEG
  • Modelo / Serial
    Lots: HURL0217, HUSB0186, HUSC0157, HUSD0382, HUSD2075.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • Descripción del producto
    Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, REF 000628, 20F.
  • Manufacturer
    C.R. Bard Access Systems, Inc
Device Recall Bard Deluxe Guidewire PEG
  • Modelo / Serial
    Lots: 43DQA112, 43EQA079, 43EQA080, 43FQA074, 43FQA097, 43GQA075, 43GQA076, 43GQA194, 43HQA079, 43HQA080, 43IQA180, 43KQA114, 43KQA115, 43LQA107.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • Descripción del producto
    Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F.
  • Manufacturer
    C.R. Bard Access Systems, Inc
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