Reported Mar 6, 2019 · Terminated
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac,…
BrosMed Medical Co.,Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BrosMed Medical Co.,Ltd. · Bubugaogaofu Lou Lou 15th · Dongguan · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Lot #'s: F1800580F1800582F1800583F1800585F1800581F1800584F1804186F1804187F1804188and F1804189
- Amount recalled
- 400
Where it was sold
Why it was recalled
Incorrect (higher) Rated Burst Pressure information printed on label.
This product could cause temporary or reversible health problems — stop using it.
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