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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description Product trade name t:slim" Insulin Delivery System Generic name Insulin Infusion Pump 510(k) Number K111210 cleared on Nov. 9, 2011 Description of the product - The Tandem t:slim" Insulin Delivery System (t:slim System or t:slim) is an Insulin Infusion Pump, product code LZG, per 21 CFR 880.5725. The t:slim System consists of the following components and accessories: (1) a software-controlled, programmable insulin infusion pump (t:slim Pump) capable of both basal and bolus delivery of insulin; (2) a dedicated, disposable 3mL (300 unit) insulin cartridge; (3) UnoMedicals Comfort" Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a Becton Dickinson 3mL sterile syringe and 26 gauge sterile needle, or equivalently cleared syringe and needle, as well as an AC power supply with USB for charging the Pumps internal battery, cartridge Instructions for Use, and Users Guide.
Recall Number Z-0827-2014
Classification Class I
Code Info Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120.
Product Distributed Qty 12, 807 boxes (10packs)
Reason For Recall Tandem Diabetes CareĀ®, Inc. announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slimĀ® Insulin Pump. The affected cartridges may be at risk for leaking. The cause of the recall was identified during Tandems internal product testing, and has not been associated with any complaints or adverse events reported by customers. However, a cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Event Detail

Event Id 67264
Product Type Devices
Status Ongoing
Recalling Firm Tandem Diabetes Care Inc
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA (nationwide)
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