Device product
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Z-1013-2019
Product summary
- Event
- Event 82068
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1013-2019
Official wording
Reason: The sterile barrier may contain packaging seal defects.
Code information: Lot 22960201
Distribution pattern: The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
Derived failure modes
-
Unknown
The sterile barrier may contain packaging seal defects.