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.
- Company
- Medtronic Minimed
- Recall Initiated
- May 16, 2011
- Posted
- November 17, 2011
- Terminated
- December 14, 2011
- Recall Number
- Z-0202-2012
- Quantity
- 4 boxes
- Firm Location
- Northridge, CA
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
Distribution
Nationwide distribution: AL only.
Lot / Code Info
Lot Number 3700255
Root Cause
Employee error
Action Taken
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.