Device Recall MICROSHEATH 0.066 (1.7mm) proximal, 0.064 (1.6mm);

  • Model / Serial
    PC MS17123; Lot# FCWC10010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
  • Product Description
    MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. || The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath¿ is a single lumen catheter that has a 123cm working length and a straight tip shape
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
  • Source
    USFDA