Z-1012-2019 Class II Terminated
FDA device recall Z-1012-2019 was initiated by Boston Scientific Corporation on Dec 26, 2018 and is designated Class II. Reason for recall: The sterile barrier may contain packaging seal defects. The recall status is terminated (terminated Apr 17, 2020). Affected quantity: 75 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2019
- Initiation Date
- Dec 26, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1012-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026