Z-0744-03

Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31 cm Venous Cuff Code #...

Name: Z-0744-03 Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31 cm Venous Cuff Code #...
Creator: Tyco Healthcare/Kendall
Published: 2003-03-20
License: https://open.fda.gov/license/

Tyco Healthcare/Kendall / initiated 2003-03-20 / Terminated

FDA source

Tyco Healthcare/Kendall began a recall of Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31 cm Venous Cuff Code #: 8888-228316 on 2003-03-20. The reason FDA records is "Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0744-03
Status: Terminated
Initiated: 2003-03-20
Posted: 2003-04-18
Terminated: 2021-05-12
Recalling firm: Tyco Healthcare/Kendall
Product: Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31 cm Venous Cuff Code #: 8888-228316
Reason for recall: Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
FDA 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 in commerce: 160
Distribution: Nationwide International: Canada, Chile, Singapore. Belgium
Product codes and lots: All lots

K002902Class IITandem-Cath 10 Fr. Catheter System, Model Multiple Code NumbersThe Kendall Company / cleared 2001-04-09

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)