FDAClass IIJune 10, 2020

EQUISTREAM¿ XK Long-Term Hemodialysis Catheter recall

EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F

Why was EQUISTREAM¿ XK Long-Term Hemodialysis Catheter recalled?

Incorrect Peel-Apart Introducer Sheath in Kit.

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 RECV3572

Product
EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
Recalling firm
Bard Peripheral Vascular Inc
Quantity
215
Distribution
67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.
Recall date
June 10, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls