FDAClass IIAugust 13, 2014

Arterial Safeset Transpac IT w/3 ml Reservoir and recall

Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated…

Why was Arterial Safeset Transpac IT w/3 ml Reservoir and recalled?

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

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?

Lot No. 2841944, 2841945, 2859326, 2865873, 2869445

Product
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated…
Recalling firm
ICU Medical, Inc.
Quantity
1,560
Distribution
Worldwide Distribution - USA including Oregon and Internationally to Australia.
Recall date
August 13, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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