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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed paradigm mio Infusion Sets

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 Class 2 Device Recall Medtronic MiniMed paradigm mio Infusion Setssee related information
Date Initiated by FirmMay 16, 2011
Date PostedNovember 17, 2011
Recall Status1 Terminated 3 on December 14, 2011
Recall NumberZ-0202-2012
Recall Event ID 59960
510(K)NumberK051264 
Product Classification Set, administration, intravascular - Product Code FPA
ProductMedtronic MiniMed paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum.
Code Information Lot Number 3700255
FEI Number 3003166194
Recalling Firm/
Manufacturer		 Medtronic Minimed
1800 Devonshire Street
Northridge CA 91325
Manufacturer Reason
for Recall		The consignee received four (4) boxes of mio infusion sets (MMT-921) that were shipped to them in error. These infusion sets were shipped in a package that included a MiniMed Paradigm REAL-TIME Insulin Pump among other items. The mio infusion sets were not authorized to be shipped to the consignee based on Medtronics internal product handling procedures and they may not function properly. T
FDA Determined
Cause 2		Employee error
ActionThe firm, Medtronic, sent an "IMPORTANT RECALL INFORMATION" letter dated May 16, 2011 to consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue use right away; use the replacement mio infusion sets provided to them in this package; return all unused Lot 3700255 mio infusion sets using the emailed pre paid return label, and drop the package off at any UPS location or call UPS at 800.742.5877 to schedule a pick up. "Please note that only the Lot 3700255 mio infusion sets were shipped in error. The other products included in the package were not shipped in error and do not need to be returned." If you have any additional questions relating to this notification or any questions in general call 800.999.9859 ext.63704.
Quantity in Commerce4 boxes
DistributionNationwide distribution: AL only.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = FPA
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