Devices

Device Recall ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters

  • 모델명 / 제조번호(시리얼번호)
    The recalled Lot Numbers are: E4MJ47, E4MF6W, E4MK84, E4MM23, E4MM64, E4MP4A, E4MR15, E4MT07, E4MT4Y, F4MU2R, F4MY91, E4MG53, E4MG5K, E4MG5L, E4MN39, E4MG89, E4MG9M, E4MH2L, E4ML6J, E4MG77, E4MG8A, E4MH18, E4MJ3K, F4MX8C, and F4N799.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- USA including the following states, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MO, MS, MT, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, and Puerto Rico.
  • 제품 설명
    ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. || Intended for transection, resection, and/or creation of anastomoses.
  • Manufacturer
    Ethicon Endo-Surgery Inc
  • 1 Event

제조사

Ethicon Endo-Surgery Inc
  • 제조사 주소
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA

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

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Device Recall ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters
  • 모델명 / 제조번호(시리얼번호)
    Lot #'s: E4MD1T, E4MD5W, E4MD3Y, E4ME7J, E4MD4Z, E4ME7U, E4MD50 & E4MF0A
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: USA only, in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI. IA. ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • 제품 설명
    ENDOPATH¿ ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969.
  • Manufacturer
    Ethicon Endo-Surgery Inc