Devices

Device Recall Bard

  • 모델명 / 제조번호(시리얼번호)
    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).
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    CA, MA
  • 제품 설명
    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

제조사

Enpath Medical, Inc.
  • 제조사 주소
    Enpath Medical, Inc., 15301 Highway 55, Plymouth MN 55447-1418
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 81 건

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Device Recall BARD DORADO
  • 모델명 / 제조번호(시리얼번호)
    LOT NUMBERS: 93FT0152
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135712
  • Manufacturer
    Bard Peripheral Vascular Inc
Device Recall BARD DORADO
  • 모델명 / 제조번호(시리얼번호)
    LOT NUMBERS: 93DT0146, 93DT0175, 93IT0211, 93IT0211
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135715
  • Manufacturer
    Bard Peripheral Vascular Inc
Device Recall Bard PEG
  • 모델명 / 제조번호(시리얼번호)
    Lots: 43FQA076, 43IQA096, 43KQA098, HURD1299, HURE3445 , HURI0365, HUSA0502, HUSC0154.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lots: HURL0217, HUSB0186, HUSC0157, HUSD0382, HUSD2075.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Lots: 43DQA112, 43EQA079, 43EQA080, 43FQA074, 43FQA097, 43GQA075, 43GQA076, 43GQA194, 43HQA079, 43HQA080, 43IQA180, 43KQA114, 43KQA115, 43LQA107.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • 제품 설명
    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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