This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPA
FDA device recall Z-0567-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- A packaging defect may compromise the device's sterility barrier.
- Action taken
- 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. Product passing Cordis inspection had a green dot put on the label and was redistributed. A representative of the account, and the inspector or sales representative signed an Acknowledgement form which in kept by Cordsi. This inspection process was completed by January 22, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- total for both devices of 39,726
- Distribution
- Product was distributed nationwide to 1035 domestic hospital accounts no international, government or military accounts.
- Date initiated
- 2003-09-26
- Date posted
- 2004-07-20
- Date terminated
- 2009-10-05
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM (K010411) | Cordis Corp. | 2001-08-27 |