FDAClass IIIFebruary 15, 2017

HOTLINE Blood and Fluid Warmer recall: Labeling Error

HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous…

Why was HOTLINE Blood and Fluid Warmer recalled?

HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling.

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?

S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.

Product
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous…
Recalling firm
Smiths Medical ASD, Inc.
Quantity
33
Distribution
Internationally to Finland
Recall date
February 15, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
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