FDAClass IIAugust 28, 2013

Medtronic MiniMed Paradigm Reservoirs recall

Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin…

Why was Medtronic MiniMed Paradigm Reservoirs recalled?

Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

MMT-326A Lot Numbers: H8437486 H8441420 H8442973 H8451531 H8486688 H8489386 H8485398 H8500423 H8500472 H8503728 H8512826 H8503372 H8510440 H8539013 H8627745 MMT-332A Lot Numbers: H8416432 H8420977 H8422490 H8424676 H8452933 H8455959 H8457716 H8459557 H8461538 H8463297 H8464121 H8467888 H8469703 H8471745 H8473271 H8476270 H8478398 H8473106 H8492449 H8491921 H8494645 H8496561 H8509305 H8512566 H8515317 H8517079 H8521052 H8541843 H8584244 H8603292 H8604958 H8635301

Product
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin…
Recalling firm
Medtronic MiniMed
Quantity
669,672 units
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela.
Recall date
August 28, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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