CLASS II Device recall · Reported 10 Jan 2018 · FDA Enforcement Report

Cadd-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF recalled

Smiths Medical ASD is recalling Cadd-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51. The recall was initiated on 22 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled58 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0307-2018
FDA event ID: 78673
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 22 Nov 2017
FDA classified: 2 Jan 2018
Reported: 10 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

22 Nov 2017	Recall initiated by company
2 Jan 2018	Classified by FDA	+41 days
10 Jan 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

Where it was distributed

US, Australia

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US, Australia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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