FDAClass IIFebruary 27, 2019

Stingray" Guidewire recall

Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during…

Why was Stingray" Guidewire recalled?

A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.

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?

Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019

Product
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during…
Recalling firm
Boston Scientific Corporation
Quantity
49 units
Distribution
Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.
Recall date
February 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls