Recall Z-1327-2014— Teleflex Medical

Name: FDA recall Z-1327-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-11

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-03-11, terminated 2016-01-28. It names one FDA 510(k) clearance: K021731. Product: 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.. Reason: Complaints of leakage of insufflation gas through the device..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Terminated: 2016-01-28
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K021731 — ADAPT OPEN ACCESS PORT, MODEL 41233Taut, Inc.·cleared 2002-08-08

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

5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Reason for recall

Complaints of leakage of insufflation gas through the device.

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