FDAClass IIMarch 6, 2019

Hermes NC PTA Balloon Dilatation Catheter The balloon recall

Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral…

Why was Hermes NC PTA Balloon Dilatation Catheter The balloon recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #'s: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.

Product
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral…
Recalling firm
BrosMed Medical Co.,Ltd.
Quantity
400
Distribution
US Distribution to MO.
Recall date
March 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls