medical Class II Updated 2019-09-04

Bard Peripheral Vascular Inc recalls EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloade

Recalled Product

EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY

Lot/Code Info: (Lot #, Exp.) RECX3719 9/30/2020; RECV3572 6/30/2020; RECU0189 4/30/2020; RECT1026 4/30/2020

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