EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
US: 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY OUS: Australia, Canada,
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2019