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 Class 2 Recall
CADD-Legacy® 1 Model 6400 Ambulatory Infusion Pump 		see related information
Date Posted April 05, 2010
Recall Number Z-1235-2010
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, Minnesota 55112-6929
Consumer Instructions Contact the recalling firm for information Contact the recalling firm for information
For Additional Information Contact Timothy Giguere
651-628-7280
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.
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
 
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