Device product
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.
Z-0585-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 75428
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-0585-2017
Official wording
Reason: Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
Code information: Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854
Distribution pattern: FL, GA, LA, OH, VA and WA.
Derived failure modes
-
Unknown
Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.