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Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation ca...

FDA Recall #Z-0852-2019 — Class II — December 19, 2018

Recall #Z-0852-2019 Date: December 19, 2018 Classification: Class II Status: Terminated

Product Description

Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Reason for Recall

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

Recalling Firm

Boston Scientific Corporation — Maple Grove, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product 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.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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