FDA Medical Device Recalls (openFDA)
Cordis Corporation: CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
- Recall number
- Z-0564-04
- Recalling firm
- Cordis Corporation
- Product
- CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L
- Status
- Terminated
- Initiated
- 2003-08-29
- Posted
- 2004-07-20
- Terminated
- 2004-05-07
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot Number 70403255
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEN
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- 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