FDAFDA · Food and drugs·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 obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.
Published March 6, 2019 · Recall initiated: December 14, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect (higher) Rated Burst Pressure information printed on label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BrosMed Medical Co.,Ltd.
- Distributor
- US Distribution to MO.
- Lot
- Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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