FDA-Device2016-11-23Class II

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.

C.R. Bard, Inc.
Hazard

Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.

Sold states
FL, GA, LA, OH, VA and WA.
Affected count
70 units
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0585-2017

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