FDAClass IIApril 16, 2014

Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product recall

Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic…

Why was Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product recalled?

Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

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?

2513261 2531612 2540540 2545044 2588656

Product
Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic…
Recalling firm
Smiths Medical ASD, Inc.
Quantity
870 units
Distribution
Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
Recall date
April 16, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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