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U.S. Department of Health and Human Services

Class 2 Device Recall CADDLegacy 1 Model 6400 Ambulatory Infusion Pump

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  Class 2 Device Recall CADDLegacy 1 Model 6400 Ambulatory Infusion Pump see related information
Date Initiated by Firm December 23, 2009
Date Posted April 05, 2010
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SIMS DELTEC, INC.
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