Recall Z-0401-2011 ยท DQO Catheter, Intravascular, Diagnostic
Millar Instruments, Inc
Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023
| Date | Nov 17, 2010 (initiated Oct 14, 2010) |
| Status | Terminated |
| Reason | The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was conducted and resulted in several samples failing. |
| Root cause | Packaging |
| Action | Millar issued a Recall Report letter on October 14, 2010 to consignees identifying the affected product, sterility issue, and actions to be taken. Customers are to return all unused catheters to Millar for replacement. Customers can contact Millar about this recall at 832-667-7131. |
| Quantity | 12 Units |
| Distribution | Worldwide Distribution: USA, including the states of MA, OH, PA, and D.C., and the countries of Canada and Germany. |
| FDA record | Open on fda.gov |