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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65644
Product Type Devices
Status Ongoing
Recalling Firm Medtronic MiniMed
City Northridge
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-03
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units 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 Class II 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 alarm to notify users. 669,672 units Z-1986-2013