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Recall Observatory FDA recall evidence

Device product

EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812

Z-2370-2019

May 31, 2019

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
Event
Event 83337
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-2370-2019

Official wording

Reason: 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.

Code information: (Lot,Exp) RECX2828, 3/31/2020

Distribution pattern: 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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.