FDAClass IIJune 1, 2016

Reprocessed Daig Supreme Fixed Curve Diagnostic recall: Labeling Error

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing…

Why was Reprocessed Daig Supreme Fixed Curve Diagnostic recalled?

Mislabeled for size

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?

Catalog Number: 401450 Lot Number: 2561683E Expiration Date: 5/13/2017 Catalog Number: 401877 Lot Number: 2555866E Expiration Date: 5/6/2017

Product
Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing…
Recalling firm
Stryker Sustainability Solutions
Quantity
18 devices
Distribution
Distributed in the state of NY and the country of Canada.
Recall date
June 1, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls