Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Reported: September 25, 2024 Initiated: July 18, 2024 #Z-3149-2024
Product Description
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
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
- 10 units
- Distribution
- US, Colombia, Philippines, Russia
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.. Recalled by Boston Scientific Corporation. Units affected: 10 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-3149-2024.
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