Z-1012-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- December 26, 2018
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 units
Product Description
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Reason for Recall
The sterile barrier may contain packaging seal defects.
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.
Code Information
Lot 22960202