FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
- Recall number
- Z-1431-2021
- Recalling firm
- C.R. Bard, Inc.
- Product
- Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
- Status
- Terminated
- Initiated
- 2021-01-11
- Posted
- not on file
- Terminated
- 2023-02-02
- Reason
- The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
- Root cause
- Packaging process control
- Action
- All customers will be contacted via letters sent via Fed Ex. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers discard affected components.
- Quantity
- 9,800 Units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Canada.
- Lot, serial or model codes
- Cat. No. 420712/Lot No. NGDY1813/ UDI (GTIN) (01)00801741038730(17)241130(10), Exp. Date 11/30/2024
- 510(k) numbers
- ["K802665"]
- PMA numbers
- not on file
- Product code
- KOD
- 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