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Class 1 Device Recall PARADIGM QUICKSET INFUSION SET |
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Date Initiated by Firm |
June 29, 2009 |
Date Posted |
July 16, 2009 |
Recall Status1 |
Terminated 3 on November 08, 2010 |
Recall Number |
Z-1705-2009 |
Recall Event ID |
52521 |
510(K)Number |
K011071
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Product Classification |
Set, administration, intravascular - Product Code FPA
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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 CA 91325
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For Additional Information Contact |
818-362-5958
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = FPA and Original Applicant = MAERSK MEDICAL A/S
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