Recall Z-2200-2008 ยท HFN Transducer, Pressure, Intrauterine
Utah Medical Products, Inc
Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047.
| Date | Sep 11, 2008 (initiated Jun 16, 2008) |
| Status | Terminated |
| Reason | Possibility of compromised package sterility prior to the expiration date. |
| Root cause | Component change control |
| Action | All consignees were notified by a faxed Recall Notice letter beginning on 6/16/2008. Customers were asked to return all unused product for immediate replacement with units that have a protective barrier within the tray packaging. The firm cautioned customers to visually inspect packaging before use. Follow-up phone calls will be made the following week. |
| Quantity | 300,000 units. |
| Distribution | Worldwide Distribution --- USA including states of CA, KS, MO, NC, NV, TX, VA, and WA and country of Japan. |
| FDA record | Open on fda.gov |