Class 2 Device Recall

• Date Initiated by Firm: November 03, 2004
• Date Posted: January 26, 2005
• Recall Status: Terminated on May 07, 2012
• Recall Number: Z-0433-05
• Recall Event ID: 30301
• 510(K)Number: K033054
• Product Classification: Pump, Infusion, Pca - Product Code MEA
• Product: Harvard 2 Syringe Pump manufactured for Rita Medical (OEM); Model Number 2005-001
• Code Information: Serial number range 218002222 - 218002382 02R00222 - 02R002382 318002383 - 318002426
• Recalling Firm/ Manufacturer: Harvard Clinical Technology; 22 Pleasant Street; Natick MA 01760
• For Additional Information Contact: Daniel 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: Other
• Action: Harvard 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 Commerce: 204 units
• Distribution: AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,
• 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 = MEA and Original Applicant = HARVARD CLINICAL TECHNOLOGY