• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Continuum MR Compatible Infusion Pump

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Continuum MR Compatible Infusion Pump see related information
Date Initiated by Firm March 22, 2005
Date Posted May 13, 2005
Recall Status1 Terminated 3 on August 17, 2005
Recall Number Z-0841-05
Recall Event ID 31565
510(K)Number K021988  K032771  
Product Classification Pump, Infusion - Product Code FRN
Product Continuum MR Compatible Infusion Pump. Pump Model #3009135
Code Information Serial numbers 1000 through 300017
Recalling Firm/
Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Laurance 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
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 in Commerce 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, Iceland, Italy, Netherlands, Norway, Portugal, Sweden, and Singapore.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FRN and Original Applicant = MEDRAD, INC.