Z-0307-2018Class II

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

Name: Z-0307-2018 CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc...
Creator: Smiths Medical ASD Inc.
Published: 2017-11-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-11-22 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY on 2017-11-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0307-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-22
Posted: 2018-01-02
Terminated: 2020-09-25
Recalling firm: Abbott Medical
Product: CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 58 units
Distribution: US, Australia
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0307-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0307-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-02

Product code FRN

K982838Class IICadd-Legacy 1 Ambulatory Infusion System Model Number 6400Sims Deltec, Inc. / cleared 1998-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)