Recall Z-0567-04 ยท MAF Stent, Coronary
Cordis Corporation
This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX Delivery System REF Cat. No. Cordis ENDOVASCULAR Lot No. Use By Cordis Europa N.V. 9301 LJ Roden The Netherlands STERILE Min. Guiding Catheter ID Nominal Pressure Rated Burst Pressure
| Date | Jul 20, 2004 (initiated Sep 26, 2003) |
| Status | Terminated |
| Reason | A packaging defect may compromise the device's sterility barrier. |
| Root cause | Other |
| Action | The firm initially mailed letters to accounts on 9/26/2003 instructing them to quarantine the indicated products pending a visit from Cordis inspectors. This mailing was followed up by one of two methods: 1) some accounts were visited by a Cordis Inspector who inspected the product at the account, and removed any potentially discrepant product and put a green dot on product which passed inspection and could be used, and 2) the remainder of the accounts were visited by Cordis Sales Representatives, in which case all product was removed from the account and returned to Cordis for inspection. |
| Quantity | total for both devices of 39,726 |
| Distribution | Product was distributed nationwide to 1035 domestic hospital accounts no international, government or military accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010411 | PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM Cordis Corp., Aug 27, 2001 |