Z-0585-2017Class II

C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by...

Name: Z-0585-2017 C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by...
Creator: C.R. Bard, Inc.
Published: 2016-10-12
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-10-12 / Terminated

FDA source

C.R. Bard, Inc. began a recall of 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 on 2016-10-12. FDA classified it as Class II and gives the reason as "Defect; The contact part could possibly separate from the electrode affecting to functionality of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0585-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Posted: 2016-11-16
Terminated: 2021-10-05
Recalling firm: C.R. Bard Inc
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.
Product code: FAS Electrode, Electrosurgical, Active, Urological
Reason for recall: Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
FDA root cause: Other
Action: Consignees were notified via letter on 10/12/2016.
Quantity in commerce: 70 units
Distribution: FL, GA, LA, OH, VA and WA.
Product codes and lots: Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0585-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0585-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

Product code FAS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)