Recall Z-1611-2013— Terumo Medical Corporation

Name: FDA recall Z-1611-2013
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: K091329. Product: Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.. 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

K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHTerumo Medical Corp.·cleared 2009-05-29

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

Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.

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.