Z-0861-2015Class II

UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The...

Name: Z-0861-2015 UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The...
Creator: US Endoscopy Group Inc
Published: 2014-10-31
License: https://open.fda.gov/license/

United States Endoscopy Group, Inc. / initiated 2014-10-31 / Terminated / root cause: manufacturing process

FDA source

US Endoscopy Group Inc began a recall of UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per... on 2014-10-31. FDA classified it as Class II and gives the reason as "Packaging non-conformance related to the integrity of the sterile pouch seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0861-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-31
Posted: 2014-12-23
Terminated: 2015-06-01
Recalling firm: United States Endoscopy Group, Inc.
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.
Product code: KOG
Reason for recall: Packaging non-conformance related to the integrity of the sterile pouch seal.
Root cause tag: manufacturing process
FDA root cause: 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 [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.
Quantity in commerce: 100 units
Distribution: Distributed to the states of FL, MO, OH and WI.
Product codes and lots: Lot 1417696

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0861-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0861-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-23

Product code KOG

K070420Class IIBioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. / cleared 2007-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)