CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- December 23, 2009
- Posted
- April 5, 2010
- Terminated
- December 10, 2011
- Recall Number
- Z-1235-2010
- Quantity
- 1
- Firm Location
- Saint Paul, MN
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.
Distribution
MI
Lot / Code Info
Serial number: 370969
Root Cause
Employee error
Action Taken
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.
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