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U.S. Department of Health and Human Services

Class 2 Device Recall Havard Clinical Technology

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  Class 2 Device Recall Havard Clinical Technology see related information
Date Initiated by Firm August 11, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-1208-03
Recall Event ID 26903
510(K)Number K952794  
Product Classification Pump, Infusion - Product Code FRN
Product Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)
Code Information Software versions V1.2R or earlier
Recalling Firm/
Manufacturer		 Harvard Clinical Technology
22 Pleasant Street
South Natick MA 01760
For Additional Information Contact Daniel B. Laferriere
508-655-2000 Ext. 261
Manufacturer Reason
for Recall		 Under specific sequence conditions, the unit may apper to be infusing, but is not
FDA Determined
Cause 2		 Other
Action Harvard Medical Technology inc. notified customers by letter on 8/11/03, advising users of the software upgrade to version V1.3T. Facilities will be visited by technicians who will upgrade the software.
Quantity in Commerce 384 units
Distribution Nationwide
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 = HARVARD APPARATUS, INC.
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