Recalls / —
—#150256
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.
- FDA product code
- FAS — Electrode, Electrosurgical, Active, Urological
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854
Why it was recalled
Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
Root cause (FDA determination)
Other
Action the firm took
Consignees were notified via letter on 10/12/2016.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- Distribution pattern
- FL, GA, LA, OH, VA and WA.
Timeline
- Recall initiated
- 2016-10-12
- Terminated
- 2021-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #150256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.