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Medical Device Recalls
Class 2 Recall
CADD-MSĀ® 3 Ambulatory Infusion Pump
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Date Recall Initiated |
March 07, 2008
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Date Posted |
August 15, 2008
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Recall Number |
Z-1621-2008
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Product |
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 homecare patients but can also used in health care facilities.
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Code Information |
USA
440038
440096
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OUSA
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Recalling Firm/ Manufacturer |
Smiths Medical MD, Inc.
1265 Grey Fox Rd
Saint Paul
, Minnesota
55112-6929
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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.
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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.
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Quantity in Commerce |
646
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Distribution |
Class II Recall - Worldwide Distribution --- USA including states of PA, TX, KY, FL, MN, GA, HI, NM, MD, and countries of CZ, GB, IT.
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