Continuum MR Compatible Infusion Pump. Pump Model #3009135
This recall has been terminated (originally issued May 13, 2005).
- Company
- Medrad Inc
- Recall Initiated
- March 22, 2005
- Posted
- May 13, 2005
- Terminated
- August 17, 2005
- Recall Number
- Z-0841-05
- Quantity
- 461 units
- Firm Location
- Indianola, PA
- Official Source
- View on FDA website ↗
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.
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, Iceland, Italy, Netherlands, Norway, Portugal, Sweden, and Singapore.
Lot / Code Info
Serial numbers 1000 through 300017
Root Cause
Other
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.