FDAClass IIJuly 8, 2015

LifeHealth recall

LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in…

Why was LifeHealth recalled?

The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.

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?

44803, 44805, 44807, 44808, 44818, 44830, 44837

Product
LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in…
Recalling firm
LifeHealth, LLC
Quantity
7
Distribution
Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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