Class 2 Device Recall CADDLegacy 1 Model 6400 Ambulatory Infusion Pump

• Date Initiated by Firm: December 23, 2009
• Date Posted: April 05, 2010
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-1235-2010
• Recall Event ID: 54284
• 510(K)Number: K982838
• Product Classification: Infusion Pump - Product Code FRN
• Product: CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.
• Code Information: Serial number: 370969
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 1265 Grey Fox Rd; Saint Paul MN 55112-6929
• For Additional Information Contact: Timothy Giguere; 651-628-7280
• Manufacturer Reason for Recall: The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.
• FDA Determined Cause: Employee error
• Action: Smiths Medical telephoned the customer on December 23, 2009, to return the CADD-Legacy 1 Ambulatory Infusion Pump, serial number 370969, since there was no record of the completed accuracy testing for the infusion pump.
• Quantity in Commerce: 1
• Distribution: MI
• 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