Recall Z-0963-2019— BrosMed Medical Co.,Ltd.
Class II · Terminated
Class II FDA medical device recall by BrosMed Medical Co.,Ltd., initiated 2018-12-14, terminated 2020-12-11. It names one FDA 510(k) clearance: K160941. Product: 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..
- Recalling firm
- BrosMed Medical Co.,Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-14
- Terminated
- 2020-12-11
- Firm location
- Dongguan, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.