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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 Recall
Medtronic MiniMed paradigm mio Infusion Sets
see related information
Date Posted November 17, 2011
Recall Status1 Terminated on December 14, 2011
Recall Number Z-0202-2012
Recall Event ID 59960
Premarket Notification
510(K) Number
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Medtronic 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
Recalling Firm/
Medtronic Minimed
1800 Devonshire Street
Northridge, California 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
TRAINING: Employee Error
Action The 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 Commerce 4 boxes
Distribution Nationwide distribution: AL only.
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 = UNOMEDICAL A/S