Z-0963-2019 Class II Terminated
FDA device recall Z-0963-2019 was initiated by BrosMed Medical Co.,Ltd. on December 14, 2018 and is designated Class II. Reason for recall: Incorrect (higher) Rated Burst Pressure information printed on label. The recall status is terminated (terminated December 11, 2020). Affected quantity: 400.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2019
- Initiation Date
- December 14, 2018
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400
Product 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 for Recall
Incorrect (higher) Rated Burst Pressure information printed on label.
Distribution Pattern
US Distribution to MO.
Code Information
Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.