Medtronic MiniMed paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are intended for the subcutaneous in

FDA device recall Z-0202-2012 · posted 2011-11-17 · Terminated

Recall details

Recalling firm

Medtronic Minimed

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

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.

Root cause

Employee error

Status

Terminated

Product code

FPA

Quantity affected

4 boxes

Distribution

Nationwide distribution: AL only.

Date initiated

2011-05-16

Date posted

2011-11-17

Date terminated

2011-12-14

Location

Northridge, CA

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