FDA Enforcement
Class II
Terminated
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
Recall: Z-0963-2019
·
Reported March 6, 2019
Enforcement
- Recall Number
- Z-0963-2019
- Event ID
- 81973
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- BrosMed Medical Co.,Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 6, 2019
- Initiation Date
- December 14, 2018
- Classification Date
- February 27, 2019
- Termination Date
- December 11, 2020
- Address
- Bubugaogaofu Lou Lou 15th, Songshan Lake Hi, Dongguan, N/A, China
Description
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
Reason
Incorrect (higher) Rated Burst Pressure information printed on label.
Code Info
Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
Distribution
US Distribution to MO.
Quantity
400