Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only).
FDA device recall Z-0941-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Reports of broken or separated tips of the catheter sheath introducers.
- Action taken
- Cordis provided their national sales force with a recall package for each customer for that representative's area for visits on 5/5/2003. The sales reps were to visit each hospital/medical facitliy to present them with the Recall Letter (dated 5/5/2003) and also a Question and Answer Sheet. The sales rep will search and quarantine for return all involved products in the customers inventory. The sales representative and customer will fill out and sign response forms and return them and the recalled product to 'Cordis Returned Goods' in Miami Lakes, FL. Due to delays in completing the visits the firm sent the same Recall Letter to all accounts that had not been visited yet on 5/30/03. In addition the Sales Reps will still visit the remaining accounts and recover recalled product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 49,022
- Distribution
- Product was distributed nationwide to 1057 hospital/medical facitilites including 33 military/VA hospitals. In addition recalled product was distributed to 7 related International Distributors in The
- Date initiated
- 2003-05-05
- Date posted
- 2003-06-12
- Date terminated
- 2008-11-19
- 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 |
|---|---|---|
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K984500) | Cordis Corp. | 1998-12-23 |
| CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM (K971608) | Cordis Corp. | 1997-07-21 |
| CORDIS BRITE TIP SHEATH INTRODUCER (K954595) | Cordis Corp. | 1995-12-28 |