Product is packaged and labeled as: ''Cordis PRECISE Nitinol Stent Transhepatic Billiary System'', Catalog Nos. N820SB,
FDA device recall Z-0323-03 · posted 2002-12-05 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Field complaints of marker band spacing being out of spec.
- Action taken
- The firm sent, via First Class Mail, a Recall notification Letter with Response Card on 11/7/02. The letter asks for response from the user accounts and for return of product. The letter includes a UPS label for return of product. Non-responders will be recontacted as part of the firm''s effectiveness checks.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 10,468
- Distribution
- Product was distributed to 620 hospital accounts nationwide. The firm did not provide information on international accounts. This info was requested from firm and RES will be updated when available.
- Date initiated
- 2002-11-07
- Date posted
- 2002-12-05
- Date terminated
- 2008-11-25
- 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 |
|---|---|---|
| MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K012993) | Cordis Corp. | 2001-10-05 |