Z-1006-04

Quickcable Autoclaveable Cable Electrode Cable

Name: Z-1006-04 Quickcable Autoclaveable Cable Electrode Cable
Creator: Biosense Webster, Inc.
Published: 2004-05-21
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2004-05-21 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of Quickcable Autoclaveable Cable Electrode Cable on 2004-05-21. The reason FDA records is "Mislabeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1006-04
Status: Terminated
Initiated: 2004-05-21
Posted: 2004-07-20
Terminated: 2005-03-31
Recalling firm: Biosense Webster Inc
Product: Quickcable Autoclaveable Cable Electrode Cable
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Reason for recall: Mislabeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recall was by letter on May 21, 2004 requesting return of affected lot.
Quantity in commerce: 212
Distribution: Nationwide, Australia, Korea, Chile, Brazil.
Product codes and lots: Lot 005955

Product code DRF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)