Recall Z-0585-2017 ยท FAS Electrode, Electrosurgical, Active, Urological
C.R. Bard, Inc.
C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.
| Date | Oct 12, 2016 |
| Status | Terminated |
| Reason | Defect; The contact part could possibly separate from the electrode affecting to functionality of the device. |
| Root cause | Other |
| Action | Consignees were notified via letter on 10/12/2016. |
| Quantity | 70 units |
| Distribution | FL, GA, LA, OH, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.