CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care patients but can also used in health care facilities.
FDA Recall Z-1621-2008 · Posted 2008-08-15
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Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2008-03-07
Date Terminated2011-12-17
Product Quantity646
Reason for Recall
Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS 3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury to the user.
Firm Action
Consignees were mailed an Urgent Medical Device Recall letter dated March 7, 2008. (Urgent Field Safety Notice dated March 7, 2008 for International Consignees.) The Urgent letter was addressed to "Risk & Safety Mangers, "Distributors", "Clinicians", "Patients" and "other Customers". The letter contains a Description of the Problem, Results of Investigation, and Advice on Action to be taken by the User which includes contacting Smiths Medical MD, Inc. Customer Service Department to make arrangements for a replacement pump. The letter also requests consignees to return the confirmation form.
Root Cause
Component change control
Distribution Pattern
Class II Recall - Worldwide Distribution --- USA including states of PA, TX, KY, FL, MN, GA, HI, NM, MD, and countries of CZ, GB, IT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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