Device Recall Insufflation Tubing Sets

  • 모델명 / 제조번호(시리얼번호)
    All Lots of the Insufflation Tubing Sets are as follows: REF 28-0206 Insufflation Tubing, Laparoscopic, Lot #29074214; REF 28-0214 Hi-Flow Insufflation Tubing Lot #3194170; REF 28-0216 Tubing, Insuf w/.3 Micr Filter Lot #29074249; REF 28-0217 Insufflation Tubing, Laparoscopic Lot #32305010; DeRoyal REF 28-0208 Insufflation Tubing w/Vent Lot #29314302; DeRoyal REF 28-0212H Heated Hi-Flow Insufflation Tubing Lot #29000354.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, FL, GA, 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, WA, WI, WV, and the countries of Dubai, Arab Emirates, Quebec, Canada, Japan, and Ireland.
  • 제품 설명
    DeRoyal Insufflation Tubing sets: || 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only || 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only || 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only || 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only || 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only || 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. || Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • 제조사 모회사 (2017)
  • Source
    USFDA