FDAClass IIMarch 4, 2015

Starburst MRI Semi-Flex Electrode Device recall

Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product…

Why was Starburst MRI Semi-Flex Electrode Device recalled?

Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.

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. 4773676, 4776428 and 4780110

Product
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product…
Recalling firm
Angiodynamics
Quantity
43
Distribution
Worldwide Distribution - US Distribution to the states of AZ, AR, FL, MI, MN, MO, NY, TX, VA, WA and WI., and to the countries of Hungary and Spain.
Recall date
March 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls