Recall Z-0963-2019 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
BrosMed Medical Co.,Ltd.
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.
| Date | Dec 14, 2018 |
| Status | Terminated |
| Reason | Incorrect (higher) Rated Burst Pressure information printed on label. |
| Root cause | Employee error |
| Action | On December 7, 2018 the firm, BrosMed Medical, sent an "URGENT FIELD SAFETY NOTICE" dated December 7, 2018 to their consignee. The notice described the product, problem and actions to be taken. The consignee was instructed to do the following: " Please reference the Attachment 1 for the list of Hermes NC PTA Balloon Dilatation Catheter with affected catalogue numbers and lots numbers. . Immediately stop selling the device from these lots. " Transfer this notification and inform relevant distributors/hospitals/clinics to check their inventory, complete and return the Effectiveness Check form |
| Quantity | 400 |
| Distribution | US Distribution to MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160941 | Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd., Dec 13, 2016 |