FDAClass IIAugust 9, 2017

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20 recall

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001

Why was Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20 recalled?

Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.

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 Numbers: QPC30107530, QPC30107745, QPC30107814, QPC30110247

Product
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
Recalling firm
Stryker Neurovascular
Quantity
63 packs
Distribution
nationwide
Recall date
August 9, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls