Recall Z-0585-2017— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-10-12, terminated 2021-10-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Defect; The contact part could possibly separate from the electrode affecting to functionality of the device..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-12
- Terminated
- 2021-10-05
- Firm location
- Covington, GA, United States
Product description
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.
Reason for recall
Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.