Home / Recalls / US Endoscopy Group Inc / Z-0861-2015

Z-0861-2015 Class II Terminated

Recalled by US Endoscopy Group Inc — Mentor, OH

Recall Details

Product Type
Devices
Report Date
December 31, 2014
Initiation Date
October 31, 2014
Termination Date
June 1, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

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.

Distribution Pattern

Distributed to the states of FL, MO, OH and WI.

Code Information

Lot 1417696

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