Dongguan, China
BrosMed Medical Co.,Ltd. recalls
1 recall recorded since 2018, most recently on 14 December 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 14 December 2018
- Terminated
- 11 December 2020
- Reason
- Incorrect (higher) Rated Burst Pressure information printed on label.
- Distribution
- US Distribution to MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0963-2019
- 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 obst
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.