Tandem Diabetes Care Inc - Insulin Infusion Pump - Class 1 Recall

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) UnoMedical s 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 Pump s internal battery, cartridge Instructions for Use, and User s Guide.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts