FDAClass IIJuly 19, 2017

Arrow EVOLUTION Pressure Injectable PICC with recall

Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Why was Arrow EVOLUTION Pressure Injectable PICC with recalled?

Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.

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?

Device Listing # D149129 Material # ASK-45552-RWJ4 PR-45552-HPHNL

Product
Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Recalling firm
Arrow International Inc
Quantity
9,037 units in the U.S. and 4,500 units internationally
Distribution
Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Recall date
July 19, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls