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(R) CRITICORE(R) MONITOR
  • 모델명 / 제조번호(시리얼번호)
    CritiCore(R) Monitor Affected Serial Numbers DYZIAA001 DYAPAA015 DYAQAA040 DYARAA045 DYBPAA010 DYBRAA020 DYBSAA020 DYBSAA065 DYZIAA002 DYAPAA016 DYARAA001 DYARAA046 DYBPAA011 DYBRAA021 DYBSAA021 DYBSAA066 DYZIAA003 DYAPAA017 DYARAA002 DYARAA047 DYBPAA012 DYBRAA022 DYBSAA022 DYBSAA067 DYZIAA004 DYAPAA018 DYARAA003 DYARAA048 DYBPAA013 DYBRAA023 DYBSAA023 DYBSAA068 DYZIAA005 DYAPAA019 DYARAA004 DYARAA049 DYBPAA014 DYBRAA024 DYBSAA024 DYBSAA069 DYZIAA006 DYAPAA020 DYARAA005 DYARAA050 DYBPAA015 DYBRAA025 DYBSAA025 DYBSAA070 DYZIAA007 DYAQAA001 DYARAA006 DYARAA051 DYBPAA016 DYBRAA026 DYBSAA026 DYBSAA071 DYZIAA008 DYAQAA002 DYARAA007 DYARAA052 DYBPAA017 DYBRAA027 DYBSAA027 DYBSAA072 DYZIAA009 DYAQAA003 DYARAA008 DYARAA053 DYBPAA018 DYBRAA028 DYBSAA028 DYBSAA073 DYZIAA010 DYAQAA004 DYARAA009 DYARAA054 DYBPAA019 DYBRAA029 DYBSAA029 DYBSAA074 DYZJAA001 DYAQAA005 DYARAA010 DYARAA055 DYBPAA020 DYBRAA030 DYBSAA030 DYBSAA075 DYZKAA001 DYAQAA006 DYARAA011 DYARAA056 DYBQAA001 DYBRAA031 DYBSAA031 DYBSAA076 DYZKAA002 DYAQAA007 DYARAA012 DYARAA057 DYBQAA002 DYBRAA032 DYBSAA032 DYBSAA077 DYZKAA003 DYAQAA008 DYARAA013 DYARAA058 DYBQAA003 DYBRAA033 DYBSAA033 DYBSAA078 DYZKAA004 DYAQAA009 DYARAA014 DYARAA059 DYBQAA004 DYBRAA034 DYBSAA034 DYBSAA079 DYZKAA005 DYAQAA010 DYARAA015 DYARAA060 DYBQAA005 DYBRAA035 DYBSAA035 DYBSAA080 DYZKAA006 DYAQAA011 DYARAA016 DYASAA001 DYBQAA006 DYBRAA036 DYBSAA036 DYBSAA081 DYZKAA007 DYAQAA012 DYARAA017 DYASAA002 DYBQAA007 DYBRAA037 DYBSAA037 DYBSAA082 DYZKAA008 DYAQAA013 DYARAA018 DYASAA003 DYBQAA008 DYBRAA038 DYBSAA038 DYBSAA083 DYZKAA009 DYAQAA014 DYARAA019 DYASAA004 DYBQAA009 DYBRAA039 DYBSAA039 DYBSAA084 DYZKAA010 DYAQAA015 DYARAA020 DYASAA005 DYBQAA010 DYBRAA040 DYBSAA040 DYBSAA085 DYZKAA011 DYAQAA016 DYARAA021 DYASAA006 DYBQAA011 DYBRAA041 DYBSAA041 DYBSAA086 DYZKAA012 DYAQAA017 DYARAA022 DYASAA007 DYBQAA012 DYBRAA042 DYBSAA042 DYBSAA087 DYZKAA013 DYAQAA018 DYARAA023 DYASAA008 DYBQAA013 DYBRAA043 DYBSAA043 DYBSAA088 DYZKAA014 DYAQAA019 DYARAA024 DYASAA009 DYBQAA014 DYBRAA044 DYBSAA044 DYBSAA089 DYZKAA015 DYAQAA020 DYARAA025 DYASAA010 DYBQAA015 DYBRAA045 DYBSAA045 DYBSAA090 DYZKAA016 DYAQAA021 DYARAA026 DYASAA011 DYBRAA001 DYBSAA001 DYBSAA046 DYBSAA091 DYZKAA017 DYAQAA022 DYARAA027 DYASAA012 DYBRAA002 DYBSAA002 DYBSAA047 DYBSAA092 DYZKAA018 DYAQAA023 DYARAA028 DYASAA013 DYBRAA003 DYBSAA003 DYBSAA048 DYBSAA093 DYZKAA019 DYAQAA024 DYARAA029 DYASAA014 DYBRAA004 DYBSAA004 DYBSAA049 DYBSAA094 DYZKAA020 DYAQAA025 DYARAA030 DYASAA015 DYBRAA005 DYBSAA005 DYBSAA050 DYBSAA095 DYAPAA001 DYAQAA026 DYARAA031 DYASAA016 DYBRAA006 DYBSAA006 DYBSAA051 DYBSAA096 DYAPAA002 DYAQAA027 DYARAA032 DYASAA017 DYBRAA007 DYBSAA007 DYBSAA052 DYBSAA097 DYAPAA003 DYAQAA028 DYARAA033 DYASAA018 DYBRAA008 DYBSAA008 DYBSAA053 DYBSAA098 DYAPAA004 DYAQAA029 DYARAA034 DYASAA019 DYBRAA009 DYBSAA009 DYBSAA054 DYBSAA099 DYAPAA005 DYAQAA030 DYARAA035 DYASAA020 DYBRAA010 DYBSAA010 DYBSAA055 DYBSAA100 DYAPAA006 DYAQAA031 DYARAA036 DYBPAA001 DYBRAA011 DYBSAA011 DYBSAA056 DYBTAA001 DYAPAA007 DYAQAA032 DYARAA037 DYBPAA002 DYBRAA012 DYBSAA012 DYBSAA057 DYBTAA002 DYAPAA008 DYAQAA033 DYARAA038 DYBPAA003 DYBRAA013 DYBSAA013 DYBSAA058 DYBTAA003 DYAPAA009 DYAQAA034 DYARAA039 DYBPAA004 DYBRAA014 DYBSAA014 DYBSAA059 DYBTAA004 DYAPAA010 DYAQAA035 DYARAA040 DYBPAA005 DYBRAA015 DYBSAA015 DYBSAA060 DYBTAA005 DYAPAA011 DYAQAA036 DYARAA041 DYBPAA006 DYBRAA016 DYBSAA016 DYBSAA061 DYBTAA006 DYAPAA012 DYAQAA037 DYARAA042 DYBPAA007 DYBRAA017 DYBSAA017 DYBSAA062 DYBTAA007 DYAPAA013 DYAQAA038 DYARAA043 DYBPAA008 DYBRAA018 DYBSAA018 DYBSAA063 DYBTAA008 DYAPAA014 DYAQAA039 DYARAA044 DYBPAA009 DYBRAA019 DYBSAA019 DYBSAA064 DYBTAA009 DYBTAA010 DYBTAA027 DYBTAA044 DYBUAA001 DYBUAA018 DYBUAA035 DYBUAA052 DYBUAA069 DYBTAA011 DYBTAA028 DYBTAA045 DYBUAA002 DYBUAA019 DYBUAA036 DYBUAA053 DYBUAA070 DYBTAA012 DYBTAA029 DYBTAA046 DYBUAA003 DYBUAA020 DYBUAA037 DYBUAA054 DYBUAA071 DYBTAA013 DYBTAA030 DYBTAA047 DYBUAA004 DYBUAA021 DYBUAA038 DYBUAA055 DYBUAA072 DYBTAA014 DYBTAA031 DYBTAA048 DYBUAA005 DYBUAA022 DYBUAA039 DYBUAA056 DYBUAA073 DYBTAA015 DYBTAA032 DYBTAA049 DYBUAA006 DYBUAA023 DYBUAA040 DYBUAA057 DYBUAA074 DYBTAA016 DYBTAA033 DYBTAA050 DYBUAA007 DYBUAA024 DYBUAA041 DYBUAA058 DYBUAA075 DYBTAA017 DYBTAA034 DYBTAA051 DYBUAA008 DYBUAA025 DYBUAA042 DYBUAA059 DYBUAA076 DYBTAA018 DYBTAA035 DYBTAA052 DYBUAA009 DYBUAA026 DYBUAA043 DYBUAA060 DYBUAA077 DYBTAA019 DYBTAA036 DYBTAA053 DYBUAA010 DYBUAA027 DYBUAA044 DYBUAA061 DYBUAA078 DYBTAA020 DYBTAA037 DYBTAA054 DYBUAA011 DYBUAA028 DYBUAA045 DYBUAA062 DYBUAA079 DYBTAA021 DYBTAA038 DYBTAA055 DYBUAA012 DYBUAA029 DYBUAA046 DYBUAA063 DYBUAA080 DYBTAA022 DYBTAA039 DYBTAA056 DYBUAA013 DYBUAA030 DYBUAA047 DYBUAA064 DYBTAA023 DYBTAA040 DYBTAA057 DYBUAA014 DYBUAA031 DYBUAA048 DYBUAA065 DYBTAA024 DYBTAA041 DYBTAA058 DYBUAA015 DYBUAA032 DYBUAA049 DYBUAA066 DYBTAA025 DYBTAA042 DYBTAA059 DYBUAA016 DYBUAA033 DYBUAA050 DYBUAA067 DYBTAA026 DYBTAA043 DYBTAA060 DYBUAA017 DYBUAA034 DYBUAA051 DYBUAA068
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution and Internationally to Japan
  • 제품 설명
    BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series || The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
  • Manufacturer
    C.R. Bard, Inc.
Device Recall Bard(R) Premature Infant Feeding Tube
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: NGAXX216, NGAVX224, NGBN2861
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 || Product Usage: || BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
  • Manufacturer
    C.R. Bard, Inc.
Device Recall Bard(R) Infant Feeding Tube
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: NGARX207, NGAX3462
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 || Product Usage: || BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
  • Manufacturer
    C.R. Bard, Inc.
Device Recall Bard(R) Adult/Pediatric Feeding Tube
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: NGAY4533, NGAX3534, NGARX206
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 || Product Usage: || BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
  • Manufacturer
    C.R. Bard, Inc.
Device Recall Bard(R) Premture Infant Feeding tube
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: NGBN2862, NGAXX217, NGAVX225
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 || Product Usage: || BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.
  • Manufacturer
    C.R. Bard, Inc.
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