FDAClass IINovember 23, 2016

Transpac¿ IV Monitoring KIT recall

TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure…

Why was Transpac¿ IV Monitoring KIT recalled?

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

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?

3192360 3210327 3225634 3242228 3242233 3242235 3242236 3242237 3242245 3242247 3242248 3242249 3242255 3242260 3242262 3242263 3253912 3264057 3264059 3264062 3264063 3273065 3273070 3273071 3284136

Product
TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 The Transpac Disposable Straight Pressure…
Recalling firm
ICU Medical, Inc.
Quantity
60,560 units
Distribution
Nationwide Distribution
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls