Device Recall Papoose Infant Spine Immobilizer, Papoose; Papoose w/replacement pads; Papoose w/o PO front;'/ pad

  • 모델명 / 제조번호(시리얼번호)
    Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad   All lot numbers from MX140101 to MX150930
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
  • 제품 설명
    Papoose Infant Spine Immobilizer || Item # Item Description: || PA-100 Papoose || PAR-100 Papoose w/replacement pads || PO-100 Papoose w/o PO front || POR-100 Papoose w/o PO front w/pad || Product Usage: || The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • 제조사 모회사 (2017)
  • Source
    USFDA