CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump recallZ-1235-2010 · Smiths Medical ASD, Inc. · initiated Dec 23, 2009
Terminated All recalls posted in April 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1235-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 23, 2009
- Posted by the FDA
- Apr 5, 2010
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 1
- Product code
- FRN
- FDA submissions
- K982838
- Distribution
- MI
Product description
CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112.
Code information (models, lots, serial numbers)
Serial number: 370969
Other devices under the same FDA submission
1 device cleared under K982838 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CADD 21-6400-51Icu Medical, Inc. · Pump, infusion7 deaths7,543 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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