Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Reported: September 25, 2024 Initiated: July 18, 2024 #Z-3148-2024
Product Description
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Reason for Recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 32 units
- Distribution
- US, Colombia, Philippines, Russia
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail. Recalled by Boston Scientific Corporation. Units affected: 32 units.
Why was this product recalled? ▼
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3148-2024.
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