Recall Z-0841-05 ยท FRN Pump, Infusion
Medrad Inc
Continuum MR Compatible Infusion Pump. Pump Model #3009135
| Date | May 13, 2005 (initiated Mar 22, 2005) |
| Status | Terminated |
| Reason | Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket. |
| Root cause | Other |
| Action | The recalling firm issued a Field Correction letter dated 3/9/05 to all their customers. The letter instructed the consignee on how to apply the new warning labels, to discard the old Operation Manual and replace it with the new one. |
| Quantity | 461 units |
| Distribution | The products were shipped nationwide to hospitals and outpatient MRI office. The product was shipped to government facilities in CA, DC, MD, NJ, SC, WA, and WV. The product was also shipped to Austriala, Canada, Mexico, United Arib, Austria, Germany, Denmark, France, Great Britain, Hong Kong, Icela |
| FDA record | Open on fda.gov |