FDA-Device2019-09-04Class II
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
Bard Peripheral Vascular Inc
Hazard
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.
Sold states
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,
Affected count
135 units
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2369-2019Don't want to check this manually?
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