Recall Z-0588-05 ยท DQY Catheter, Percutaneous
Cordis Corporation
Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S
| Date | Mar 10, 2005 (initiated May 5, 2004) |
| Status | Terminated |
| Reason | The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters. |
| Root cause | Other |
| Action | A recall letter dated 04/30/2004 was sent to the consignees, instructing them to discontinue using the product and informed them that a Cordis representive would remove any unit in their possesion. |
| Quantity | 40 |
| Distribution | Distributed in FL, OK, SC, and KS in the US. Internationaly to South Africa and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001136 | CORDIS INTRODUCER GUIDE Cordis Corp., Apr 28, 2000 |