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.
FDA Recall Z-0861-2015 · Posted 2014-12-23
Advertisement
Recalling FirmUS Endoscopy Group Inc
Recall StatusTerminated
Product CodeKOG
Date Initiated2014-10-31
Date Terminated2015-06-01
Product Quantity100 units
Reason for Recall
Packaging non-conformance related to the integrity of the sterile pouch seal.
Firm Action
Consignees were notified by phone, e-mail, and an Urgent: US Endoscopy UroSeal Adjustable Valve Recall letter. The letter identified the affected product and the reason for the recall. Customers were asked to remove any affected product from their inventory and quarantine them. Additionally, customers were to complete and return the attached Customer Response Card to Kia Pennington via fax at 1-440-639-4495 or e-mail at [email protected] as soon as possible. The firm contacted customers regarding the RMA instructions and replacement product. Customers were to follow the RMA instructions in order to receive an RMA number and return the affected product. Questions should be directed towards Kia Pennington in Customer Service at 1-800-769-8229.
Root Cause
Equipment maintenance
Distribution Pattern
Distributed to the states of FL, MO, OH and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement