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US Endoscopy Group Inc recalls UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary p
Recalled December 31, 2014 · FDA recall Z-0861-2015 · US Endoscopy Group
Hazard
Packaging non-conformance related to the integrity of the sterile pouch seal. · FDA Class II
Units
100 units
Sold at
Distributed to the states of FL, MO, OH and WI.
Description
Packaging non-conformance related to the integrity of the sterile pouch seal.
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.
Manufacturer(s)
US Endoscopy Group Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →