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U.S. Department of Health and Human Services

Class 2 Device Recall CADDLegacy

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  Class 2 Device Recall CADDLegacy see related information
Date Initiated by Firm November 22, 2017
Date Posted January 02, 2018
Recall Status1 Terminated 3 on September 25, 2020
Recall Number Z-0307-2018
Recall Event ID 78673
510(K)Number K982838  
Product Classification infusion pump - Product Code FRN
Product CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Code Information 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
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
763-383-3072
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SIMS DELTEC, INC.
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