Recall Z-0941-03 ยท DYB Introducer, Catheter
Cordis Corporation
Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only).
| Date | Jun 12, 2003 (initiated May 5, 2003) |
| Status | Terminated |
| Reason | Reports of broken or separated tips of the catheter sheath introducers. |
| Root cause | Other |
| Action | 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 |
| Quantity | 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 Netherlands, Brazil, Canada, Chile, Columbia, Mexico and Venezuela. |
| FDA record | Open on fda.gov |