CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF… recallZ-0307-2018 · Smiths Medical ASD Inc. · initiated Nov 22, 2017
Class II Terminated All recalls posted in January 2018
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
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0307-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 22, 2017
- Posted by the FDA
- Jan 2, 2018
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 58 units
- Product code
- FRN
- FDA submissions
- K982838
- Distribution
- US, Australia
Product description
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Code information (models, lots, serial numbers)
Serial Numbers: 409963, 409964, 409965, 409966, 409967, 409968, 409969, 409970, 409971, 409972, 409973, 409974, 409975, 409976, 409977, 409978, 409979, 409980, 409981, 409982, 409983, 409984, 409985, 409986, 409987, 409988, 409989, 409990, 409991, 409992, 409993, 409994, 409995, 409996, 409997, 409998, 409999, 410000, 410001, 410002, 410003, 410004, 410005, 410006, 410007, 410008, 410009, 410010, 410011, 410012, 410013, 410014, 410015, 410016, 410017, 410018, 410019, 410020
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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