Device Recall Pleurevac Chest Drainage System

  • 모델명 / 제조번호(시리얼번호)
    Product Code A-1500-08LF - Lot/Batch Numbers: 74J1501715, 74K1501006, 74L1500163; Product Code A-430-08LF - Lot/Batch Numbers: 74K1500975, 74K1502313, 74L1500164, 74L1500165; Product Code A-6000-08LF - Lot/Batch Numbers: 74K1500364, 74K1500365, 74K1500367, 74K1500907, 74K1500908, 74K1501007, 74K1501008, 74K1501010, 74K1501014, 74K1502274, 74L1502302, 74L1502304; Product Code A-6002-08LF - Lot/Batch Numbers: 74K1500391, 74K1500909, 74K1500910, 74K1503003, 74L1500179; Product Code A-6020-08LF - Lot/Batch Number: 74L1500180; Product Code A-7000-08LF - Lot/Batch Numbers: 74K1500372, 74K1500913, 74K1501021, 74K1502277; Product Code A-8000-08LF - Lot/Batch Numbers: 74K1500369, 74K1500915, 74K1501025, 74K1501026, 74K1501028, 74K1502263, 74K1502264, 74L1500190; Product Code A-8002-08LF - Lot/Batch Numbers: 74K1500376, 74K1501032; Product Code S-0500 - Lot/Batch Number: 74K1500379; Product Code S-100-08LF - Lot/Batch Number: 74K1501039; Product Code S-1100-08LF - Lot/Batch Numbers: 74K1500381, 74K1501041, 74K1502267, 74L1500208, 74L1500209, 74L1500210; Product Code S-1102-08LF - Lot/Batch Numbers: 74K1500382, 74K1500383; Product Code S-1103-08LF - Lot/Batch Number: 74K1500922; Product Code S-1150-08LF - Lot/Batch Number: 74J1501725; Product Code S-1200-08LF - Lot/Batch Numbers: 74K1500385, 74K1501043
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, LA, MD, MA, MI, MS, MO. MT, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WV, Puerto Rico, Belgium, Canada, Chile, Dominican Republic & Germany
  • 제품 설명
    Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical. || Product Usage: || Pleur-Evacs are sterile, single-use, chest drainage systems intended for post-operative use
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • 제조사 모회사 (2017)
  • Source
    USFDA