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Terminated

Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6 versus 9mm)

FDA Recall Z-0910-04 · Posted 2012-03-19

Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeFPA
Date Initiated2004-03-02
Date Terminated2012-03-19
Product QuantityUndetermined

Reason for Recall

Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004.

Firm Action

Firm will ship all users (customers) one box at a time every three weeks for the next several months. A recall notification letter was issued to users and to healthcare professionals, and distributors. Letters were mailed from March 2-5, 2004.

Root Cause

Component design/selection

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030149MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9Avail Medical Products, Inc. · 2003-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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