Continuum MR Compatible Infusion Pump. Pump Model #3009135
FDA device recall Z-0841-05 · posted 2005-05-13 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 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 Austria
- Date initiated
- 2005-03-22
- Date posted
- 2005-05-13
- Date terminated
- 2005-08-17
- Location
- Indianola, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD CONTINUUM MR INFUSION SYSTEM (K032771) | Medrad, Inc. | 2003-09-23 |
| MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM (K021988) | Medrad, Inc. | 2002-08-29 |