Recall Z-0725-2018— Terumo Medical Corporation

Name: FDA recall Z-0725-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-12

Class II · Terminated

Class II FDA medical device recall by Terumo Medical Corporation, initiated 2017-09-12, terminated 2018-08-31. It names one FDA 510(k) clearance: K012584. Product: Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.. Reason: The tucking depth feature of this catheter introducer is marginally outside the upper specification..

Recalling firm: Terumo Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-09-12
Terminated: 2018-08-31
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K012584 — MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KITBd·cleared 2001-09-06

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

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 Product Usage: The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

Reason for recall

The tucking depth feature of this catheter introducer is marginally outside the upper specification.

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