Recall Z-2781-2017— Greatbatch Medical

Name: FDA recall Z-2781-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-11

Class II · Terminated

Class II FDA medical device recall by Greatbatch Medical, initiated 2016-11-11, terminated 2017-11-03. It names one FDA 510(k) clearance: K072248. Product: ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006. Reason: Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use..

Recalling firm: Greatbatch Medical
Classification: Class II
Status: Terminated
Initiated: 2016-11-11
Terminated: 2017-11-03
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K072248 — VIAPEEL PEELABLE INTRODUCEREnpath Medical, Inc.·cleared 2007-11-09

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

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

Reason for recall

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

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