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U.S. Department of Health and Human Services

Class 2 Device Recall Continuum MR Compatible Infusion Pump

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 Class 2 Device Recall Continuum MR Compatible Infusion Pumpsee related information
Date Initiated by FirmMarch 22, 2005
Date PostedMay 13, 2005
Recall Status1 Terminated 3 on August 17, 2005
Recall NumberZ-0841-05
Recall Event ID 31565
510(K)NumberK021988 K032771 
Product Classification Pump, Infusion - Product Code FRN
ProductContinuum MR Compatible Infusion Pump. Pump Model #3009135
Code Information Serial numbers 1000 through 300017
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information ContactLaurance R. Kopyta
412-767-2400 Ext. 3621
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce461 units
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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