Recall Z-1612-2013— Terumo Medical Corporation

Name: FDA recall Z-1612-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-30

Class II · Terminated

Class II FDA medical device recall by Terumo Medical Corporation, initiated 2013-05-30, terminated 2013-10-30. It names one FDA 510(k) clearance: K102008. Product: Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.. Reason: Medical devices were incorrectly labeled with extended expiration dates..

Recalling firm: Terumo Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-05-30
Terminated: 2013-10-30
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K102008 — GLIDESHEATHTerumo Medical Corp.·cleared 2010-07-21

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

Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.

Reason for recall

Medical devices were incorrectly labeled with extended expiration dates.

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