CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 5511
FDA device recall Z-1235-2010 · posted 2010-04-05 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- 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 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 1
- Distribution
- MI
- Date initiated
- 2009-12-23
- Date posted
- 2010-04-05
- Date terminated
- 2011-12-10
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 (K982838) | Sims Deltec, Inc. | 1998-11-04 |