FDAClass IINovember 23, 2016

Transpac¿ IV Bifurcated Monitoring KIT recall

TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No.…

Why was Transpac¿ IV Bifurcated 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?

3261534 3274777

Product
TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No.…
Recalling firm
ICU Medical, Inc.
Quantity
260 units
Distribution
Nationwide Distribution
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls