Smiths Medical ASD, Inc. CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Serial number: 370969
Products Sold
Serial number: 370969
Smiths Medical ASD, Inc. is recalling CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, In due to The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI
Page updated: Jan 10, 2026