Recall Z-1143-2015— Angiodynamics

Name: FDA recall Z-1143-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by Angiodynamics, initiated 2014-12-19, terminated 2015-11-27. It names one FDA 510(k) clearance: K992693. 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 No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615. Reason: 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..

Recalling firm: Angiodynamics
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2015-11-27
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K992693 — RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90Rita Medical Systems·cleared 1999-09-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.