FDA Medical Device Recalls (openFDA)
C.R. Bard Inc: BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
- Recall number
- Z-0667-2022
- Recalling firm
- C.R. Bard Inc
- Product
- BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
- Status
- Terminated
- Initiated
- 2022-01-27
- Posted
- not on file
- Terminated
- 2026-07-10
- Reason
- There is a potential to leak from the catheter where it connects to the drain bag
- Root cause
- Under Investigation by firm
- Action
- The firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall.
- Quantity
- 1620 units
- Distribution
- US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
- Lot, serial or model codes
- Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)
- 510(k) numbers
- ["K000723"]
- 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