FDAClass IIAugust 6, 2014

DeRoyal Cardiac Hypothermia Tray recall

DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

Why was DeRoyal Cardiac Hypothermia Tray recalled?

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

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 Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

Product
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Recalling firm
DeRoyal Industries Inc
Quantity
230 units
Distribution
Distributed in the states of MI, GA, OH, IL, MO, and IN.
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls