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U.S. Department of Health and Human Services

Class 2 Device Recall UroSeal Adjustable Endoscopic Valve

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  Class 2 Device Recall UroSeal Adjustable Endoscopic Valve see related information
Date Initiated by Firm October 31, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on June 01, 2015
Recall Number Z-0861-2015
Recall Event ID 69809
510(K)Number K070420  
Product Classification Endoscope and/or accessories - Product Code KOG
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.
Code Information Lot 1417696
Recalling Firm/
US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information Contact Kia Pennington
Manufacturer Reason
for Recall
Packaging non-conformance related to the integrity of the sterile pouch seal.
FDA Determined
Cause 2
Equipment maintenance
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 recall@usendoscopy.com 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.
Quantity in Commerce 100 units
Distribution Distributed to the states of FL, MO, OH and WI.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = UNITED STATES ENDOSCOPY GROUP, INC.