—#88142

Product

CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K982838
Affected lot / code info: Serial number: 370969

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: MI

Timeline

Recall initiated: 2009-12-23
Posted by FDA: 2010-04-05
Terminated: 2011-12-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88142. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.