Recall Z-0585-2017
C.R. Bard, Inc. · initiated October 12, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854
Reason for recall
Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
FDA-determined cause: Other
Action taken
Consignees were notified via letter on 10/12/2016.
Details
- Recall number
- Z-0585-2017
- Initiated
- October 12, 2016
- Terminated
- October 5, 2021
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Quantity
- 70 units
- Distribution
- FL, GA, LA, OH, VA and WA.
- Recalling firm
- C.R. Bard, Inc., Covington, GA