Recall Z-0861-2015 ยท KOG
US Endoscopy Group Inc
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.
| Date | Dec 23, 2014 (initiated Oct 31, 2014) |
| Status | Terminated |
| Reason | Packaging non-conformance related to the integrity of the sterile pouch seal. |
| 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 recall@usendoscopy.com as soon as possible. The firm contacted customers regarding the RMA instructions and replacement product. Customers were to follow the RMA instructi |
| Quantity | 100 units |
| Distribution | Distributed to the states of FL, MO, OH and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070420 | BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 United States Endoscopy Group, Inc., Mar 19, 2007 |