FDA-Device2014-12-31Class II
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.
US Endoscopy Group Inc
Hazard
Packaging non-conformance related to the integrity of the sterile pouch seal.
Sold states
Distributed to the states of FL, MO, OH and WI.
Affected count
100 units
Manufactured in
5976 Heisley Rd, Mentor, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2015Don't want to check this manually?
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