FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: 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.
- Recall number
- Z-0585-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-10-12
- Posted
- not on file
- Terminated
- 2021-10-05
- Reason
- Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
- Root cause
- Other
- Action
- Consignees were notified via letter on 10/12/2016.
- Quantity
- 70 units
- Distribution
- FL, GA, LA, OH, VA and WA.
- Lot, serial or model codes
- Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FAS
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28