Z-0564-04

CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L

Name: Z-0564-04 CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
Creator: Cordis Corporation
Published: 2003-08-29
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2003-08-29 / Terminated / root cause: labeling and UDI

FDA source

Cordis Corporation began a recall of CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L on 2003-08-29. The reason FDA records is "Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104mm". 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-0564-04
Status: Terminated
Initiated: 2003-08-29
Posted: 2004-07-20
Terminated: 2004-05-07
Recalling firm: Cordis US Corp.
Product: CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
Product code: GEN Forceps, General & Plastic Surgery
Reason for recall: Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104mm.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm initially sent Cordis representatives to visit all 21 domestic accounts the week of August 25, 2003. Follow-up Recall notificaiton Letters were sent to each account discussing the problem and informing them that a Cordis Representative has been at their location and inspected their product for misbranded devices. In 18 cases the letter stated that NO mislabeled product was found but in three other cases they were told that mislabeled product was found and recovered. These follow-up letters to the visits were sent out on August 29, 2003. A similar inspection was performed by Cordis Representatives for International Accounts and the Recall Notification was sent to the International Accounts on 8/29/2003.
Quantity in commerce: 220
Distribution: The devices were distributed to 21 domestic hospital accounts in MI, OK, FL, TN, NY, IN, VA, NC, WI, GA, IA, NE, CA. Also product was distributed to International Distributors in the Netherlands, Canada and Mexico.
Product codes and lots: Lot Number 70403255

Product code GEN

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)