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.
Recall
- Recall Number
- Z-1621-2008
- Event Number
- 47767
- Firm
- Smiths Medical MD, Inc.
- FEI Number
- 2183502
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- March 7, 2008
- Posted
- August 15, 2008
- Terminated
- December 17, 2011
- Address
- 1265 Grey Fox Rd, Saint Paul, MN, 55112-6929
Description
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.
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.
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.
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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