FDA Device recall Z-1012-2019
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
- FDA Device
- Class II
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class II recall of Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220 by Boston Scientific, citing the sterile barrier may contain packaging seal defects.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1012-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-26 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | AL, CA, IL, MD, PA, TN, TX, UT, WI |
Product
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Reason
The sterile barrier may contain packaging seal defects.
Identifiers
| code_info | Lot 22960202 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1012-2019%22
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