Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • 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 Recallsee related information
Date Initiated by FirmNovember 03, 2004
Date PostedJanuary 26, 2005
Recall Status1 Terminated 3 on May 07, 2012
Recall NumberZ-0433-05
Recall Event ID 30301
510(K)NumberK033054 
Product Classification Pump, Infusion, Pca - Product Code MEA
ProductHarvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
Code Information Serial number range 218002222 - 218002382  02R00222 - 02R002382 318002383 - 318002426 
FEI Number 1218257
Recalling Firm/
Manufacturer		 Harvard Clinical Technology
22 Pleasant Street
Natick MA 01760
For Additional Information ContactDaniel B. Laferriere
781-596-7750
Manufacturer Reason
for Recall		Potential pump motor/encoder assembly failure may cause over infusing medication in patients
FDA Determined
Cause 2		Other
ActionHarvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.
Quantity in Commerce204 units
DistributionAK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,
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 = MEA
-
-