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.
Recall
- Recall Number
- Z-0861-2015
- Event Number
- 69809
- Firm
- US Endoscopy Group Inc
- FEI Number
- 1000122656
- Product Code
- KOG
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- October 31, 2014
- Posted
- December 23, 2014
- Terminated
- June 1, 2015
- Address
- 5976 Heisley Rd, Mentor, OH, 44060-1873
Description
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.
Packaging non-conformance related to the integrity of the sterile pouch seal.
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.
Distributed to the states of FL, MO, OH and WI.
100 units