Recall Z-0861-2015— US Endoscopy Group Inc

Name: FDA recall Z-0861-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-31

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2014-10-31, terminated 2015-06-01. It names one FDA 510(k) clearance: K070420. Product: UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.. Reason: Packaging non-conformance related to the integrity of the sterile pouch seal..

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2014-10-31
Terminated: 2015-06-01
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K070420 — BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138United States Endoscopy Group, Inc.·cleared 2007-03-19

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

UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.

Reason for recall

Packaging non-conformance related to the integrity of the sterile pouch seal.

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