Device Recall Insufflation Tubing Sets

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
  • Source
    USFDA