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 Recall Z-0585-2017 · Posted None
Advertisement
Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeFAS
Date Initiated2016-10-12
Date Terminated2021-10-05
Product Quantity70 units
Reason for Recall
Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
Firm Action
Consignees were notified via letter on 10/12/2016.
Root Cause
Other
Distribution Pattern
FL, GA, LA, OH, VA and WA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement