Recall Z-0055-06 ยท DQO Catheter, Intravascular, Diagnostic
Origen Biomedical, Inc
Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744
| Date | Oct 15, 2005 (initiated Dec 16, 2002) |
| Status | Terminated |
| Reason | Leak between two lumens causes reduced performance. |
| Root cause | Other |
| Action | The recall was initiated by letter to all consignees on 12/16/2002. |
| Quantity | 170 catheters |
| Distribution | The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.