Z-0861-2015 Class II Terminated
FDA device recall Z-0861-2015 was initiated by US Endoscopy Group Inc on October 31, 2014 and is designated Class II. Reason for recall: Packaging non-conformance related to the integrity of the sterile pouch seal. The recall status is terminated (terminated June 1, 2015). Affected quantity: 100 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- October 31, 2014
- Termination Date
- June 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 units
Product 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.
Reason for Recall
Packaging non-conformance related to the integrity of the sterile pouch seal.
Distribution Pattern
Distributed to the states of FL, MO, OH and WI.
Code Information
Lot 1417696