Devices

AirLife

  • 모델명 / 제조번호(시리얼번호)
    1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668;  2) Product Code 2K8004; Lot Number: 0000355673;  3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677;  4) Product Code 2K8034; Lot Number: 0000355688;  5) Product Code 2K8035; Lot Number: 0000358023;  6) Product Code 2K8037; Lot Number: 0000358025;  7) Product Code 2K8040; Lot Number: 0000358026
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA
  • 제품 설명
    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; || 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; || 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; || 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; || 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; || 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; || 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock || Product Usage: Pulmonary resuscitation
  • Manufacturer
    Carefusion 2200 Inc
  • 1 Event

제조사

Carefusion 2200 Inc
  • 제조사 주소
    Carefusion 2200 Inc, 1500 S Waukegan Rd, Mpwm Bldg., Waukegan IL 60085-6728
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 50 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot Number 0001047501
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
  • 제품 설명
    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION || Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
  • Manufacturer
    Vyaire Medical
Device Recall Infant AirLife
  • 모델명 / 제조번호(시리얼번호)
    CM17H12 CM17H16 CM17H17 CM17H19 CM17H20 CM17J27 CM17J28 CM17J29 CM17J30 CM17K09 CM17K20 CM17K21 CM17K22 CM17K23
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290. || The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
  • Manufacturer
    Vyaire Medical
Device Recall Infant AirLife Duallimb
  • 모델명 / 제조번호(시리얼번호)
    0001115635 0001115640 0001124941 0001124942 0001124943 0001124944 0001129628 0001134758 0001134759
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. || The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
  • Manufacturer
    Vyaire Medical
Device Recall Adult AirLife singlelimb
  • 모델명 / 제조번호(시리얼번호)
    0001115270 0001121993 0001124929 0001 124930 0001 124932 0001129063 0001 129064 0001131424 0001131425 0001 134347 0001134348 0001135401 0001135402 0001137252 0001137253 0001139266 0001139267 0001145147 0001145148 0001145149 0001156843
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. || The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
  • Manufacturer
    Vyaire Medical
Device Recall Adult AirLife duallimb
  • 모델명 / 제조번호(시리얼번호)
    0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290. || The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
  • Manufacturer
    Vyaire Medical
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