FDAClass IIJuly 17, 2019

MAHURKAR and Argyle acute hemodialysis catheters recall

MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005…

Why was MAHURKAR and Argyle acute hemodialysis catheters recalled?

The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.

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?

All lots

Product
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005…
Recalling firm
COVIDIEN LLC
Quantity
2,223,067
Distribution
Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong.
Recall date
July 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls