Recall Z-1421-2010 ยท DYB Introducer, Catheter
Cordis Corporation
Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.
| Date | Apr 20, 2010 (initiated Jan 28, 2010) |
| Status | Terminated |
| Reason | Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in packing trays. |
| Root cause | Package design/selection |
| Action | Cordis initiated the recall January 28, 2010. (The packets were sent overnight on January 28, 2010, with first receipt by customers January 29, 2010.) Immediate corrective action was taken through an inspection and removal of all affected products. |
| Quantity | 1850 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945616 | CORDIS AVANTI CATHETER SHEATH INTRODUCER Cordis Corp., Mar 29, 1995 |