Class 2 Device Recall Havard Clinical Technology

• Date Initiated by Firm: August 11, 2003
• Date Posted: September 11, 2003
• Recall Status: Terminated 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
• FEI Number: 1218257
• 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: 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