FDAClass IIOctober 12, 2016

Walrus Arterial Embolectomy Catheter The arterial recall: Labeling Error

Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.

Why was Walrus Arterial Embolectomy Catheter The arterial recalled?

Arrow is recalling due to incorrect labeling of products.

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/Batch 14F15H0292, 14F15J0139, 14F15A0174, CF3016366, 14F14E0300, 14F15G0349, 14F15H0261, CF2079921, 14F15J0363, 14F14J0155, 14F15F0406, 14F15E0263, 14F15H0258, 14F15H0251, 14F15G0347. CF2125865, 14F15D0197, 14F15H0025, 14F15H0332, 14F15B0244, 14F15G0348

Product
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Recalling firm
Arrow International Inc
Quantity
2,425 catheters
Distribution
US Nationwide Distribution
Recall date
October 12, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls