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U.S. Department of Health and Human Services

Class 1 Device Recall PARADIGM QUICKSET INFUSION SET

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 Class 1 Recall
PARADIGM QUICKSET INFUSION SET
see related information
Date Posted July 16, 2009
Recall Status1 Terminated on November 08, 2010
Recall Number Z-1705-2009
Recall Event ID 52521
Premarket Notification
510(K) Number
K011071 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm external insulin infusion pumps to deliver insulin (subcutaneously) to patients who require exogenous insulin to maintain glycemic control.
Code Information Lot numbers starting with the Number 8.
Recalling Firm/
Manufacturer
Medtronic MiniMed
18000 Devonshire St
Northridge, California 91325
Manufacturer Reason
for Recall
Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Medtronic issued an "URGENT MEDICAL DEVICE RECALL" notification letter dated July 6, 2009 to health care professionals, followed by notification letters dated July 7, 2009 to distributors, inactive and active customers. Letters to healthcare professionals and distributors were sent via UPS 2-Day Air with signature confirmation of delivery required. On July 8, 2009 and July 9, 2009, a notification letter, along with replacements sets, were mailed via UPS to active patients or customers (who have ordered since January 2009). The notification letter to patients (inactive customers) who last ordered prior to January 1, 2009 were issued via First Class U.S. Mail. All letters to patients include a preaddressed, postage paid card to confirm that the patient has received the recall notice and to identify whether or not they have unused sets to return. As described in the patient letters, patients have the option to confirm receipt of the notification and to order replacement infusion sets online or via an automated telephone voice response system. Distributors who purchased affected Paradigm Quick-set infusion sets must either notify all patients to whom they have provided infusion sets or provide patient names and addresses to Medtronic MiniMed so that the firm can carry out the notification. The firm's website, www.medtronicdiabetes.com/lot8, is available for customer concerns and questions not addressed in the recall letter. The website is also the most efficient way to exchange Lot 8 Quick-set infusion sets and/or place new supply orders. In the event the above website is not accessible or for additional questions, please call 1-800-345-8139 at Medtronic Diabetes 24- hours a day. Doctors who would like to speak with a Medtronic Diabetes medical officer may call 1-818-576-4211, 24-hours a day. Report product problems by calling 1-800-345-8139 at any time. Medtronic issued a press release on July 10, 2009.
Quantity in Commerce 28,007,256 units
Distribution Worldwide Distribution -- US, Canada, Mexico, Bermuda, Brazil, United Kingdom, Ecuador, Paraguay, Kuwait, Germany, El Salvador and Turkey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = MAERSK MEDICAL A/S
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