FDA Medical Device Recalls (openFDA)
Tyco Healthcare/Kendall: Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266
- Recall number
- Z-0743-03
- Recalling firm
- Tyco Healthcare/Kendall
- Product
- Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266
- Status
- Terminated
- Initiated
- 2003-03-20
- Posted
- 2003-04-18
- Terminated
- 2021-05-12
- Reason
- Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Root cause
- Other
- Action
- The firm notified accounts by letter on 3/20/03 by overnight mail delivery. Users are requested to examine, remove and return product.
- Quantity
- 254
- Distribution
- Nationwide International: Canada, Chile, Singapore. Belgium
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K002902"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- not on file
- Firm city
- Mansfield
- Firm state
- MA
- 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