FDAClass IISeptember 4, 2019

EQUISTREAM Long-Term Hemodialysis Catheter with recall

EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690

Why was EQUISTREAM Long-Term Hemodialysis Catheter with 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 #, Exp.) RECZ3009 8/31/2020 RECZ0716 7/31/2020 RECW0585 7/31/2020 RECX1187 8/31/2020 RECV1624 1/31/2020

Product
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
Recalling firm
Bard Peripheral Vascular Inc
Quantity
1356 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)
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