Recall Z-1828-2008 ยท DXT Injector And Syringe, Angiographic
Mallinckrodt Inc
Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
| Date | Sep 3, 2008 (initiated Apr 14, 2008) |
| Status | Terminated |
| Reason | The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug. |
| Root cause | Device Design |
| Action | Letter dated April 18, 2008. The firm has requested their customers check their inventory, and determine if they have any of the affected suspension systems. If they observe any loose screws or cracking around the J-Bow tube, immediately take the system out of service. A service representative will contact them to schedule any required system corrections. For assistance, contact Product Monitoring Department at 1-800-778-7898 or by email at productmonitoringhazelwood@covidien.com. |
| Quantity | 2546 pieces |
| Distribution | Product was sold in 46 US states: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV & WY, |
| FDA record | Open on fda.gov |