medical Class II Updated 2019-03-06

BrosMed Medical Co.,Ltd. recalls Hermes NC PTA Balloon Dilatation Catheter The balloon dil

Recalled 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.

Hazard / Issue

Incorrect (higher) Rated Burst Pressure information printed on label.

Issued by

FDA

Affected States: MO
Lot/Code Info: Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
View official government recall

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