FDAClass IISeptember 4, 2019

EQUISTREAM XK Alphacurve Long-Term Hemodialysis recall

EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904

Why was EQUISTREAM XK Alphacurve Long-Term Hemodialysis recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # REDN1368 Exp. 9/30/2020

Product
EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
Recalling firm
Bard Peripheral Vascular Inc
Quantity
0 units
Distribution
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,
Recall date
September 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls