Recall Z-1725-2011 ยท DQO Catheter, Intravascular, Diagnostic
Millar Instruments, Inc
Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.
| Date | Mar 24, 2011 (initiated Mar 8, 2011) |
| Status | Terminated |
| Reason | Possibility of epoxy debris particles inside the catheter lumen. |
| Root cause | Process design |
| Action | The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed. If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000. |
| Quantity | 1080 units |
| Distribution | MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway. |
| FDA record | Open on fda.gov |