Device 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.
Z-0861-2015
Product summary
- Event
- Event 69809
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units
- Official record key
device-enforcement:Z-0861-2015
Official wording
Reason: Packaging non-conformance related to the integrity of the sterile pouch seal.
Code information: Lot 1417696
Distribution pattern: Distributed to the states of FL, MO, OH and WI.
Derived failure modes
-
Unknown
Packaging non-conformance related to the integrity of the sterile pouch seal.