Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Reported: March 20, 2019 Initiated: December 26, 2018 #Z-1012-2019
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 75 units
- Distribution
- 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.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220. Recalled by Boston Scientific Corporation. Units affected: 75 units.
Why was this product recalled? ▼
The sterile barrier may contain packaging seal defects.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2019. Severity: Moderate. Recall number: Z-1012-2019.
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