CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
FDA device recall Z-0307-2018 · posted 2018-01-02 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.
- Action taken
- The recall notices were disseminated via FedEx to US consignees on November 22, 2017. The recall notices were disseminated via email to Australian consignees on November 27, 2017. The consignee was directed to turn on the pump and check the serial against the serial number on the label. If they did not match, then they were directed to return the unit.
- Root cause
- Process design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 58 units
- Distribution
- US, Australia
- Date initiated
- 2017-11-22
- Date posted
- 2018-01-02
- Date terminated
- 2020-09-25
- Location
- Minneapolis, 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 |