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[IP] T-slim cartridge recall



Sarah Sugabetic just posted this notice from Tandem:
I don't have any of these...
Denise Br.

___________________________________________________________________________________________________________
just received this email. If you use the Tandem t:slim insulin pump, 
check your cartridges for these lot numbers and give them a call.

    FOR IMMEDIATE RELEASE

    Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of
    Insulin Cartridges Used with t:slim Insulin Pump
    Company Is Providing Replacement Cartridges to Its Customers at No
    Additional Charge

    Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of
    Insulin Cartridges Used with t:slim Insulin Pump
    Company Is Providing Replacement Cartridges to Its Customers at No
    Additional Charge

    SAN DIEGO, January 10, 2014  Tandem Diabetes Care., Inc. (NASDAQ:
    TNDM) today announced that it is initiating a voluntary recall of
    specific lots of insulin cartridges that are used with the t:slim.
    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.

    The safety of our customers is our top priority, and we are
    committed to quickly addressing issues if they arise, said Kim
    Blickenstaff, President and CEO of Tandem Diabetes Care. The
    potential for a cartridge leak was identified during in-house
    product testing, and the cause has been identified. Modifications to
    our cartridge manufacturing process have been implemented to prevent
    this issue from occurring in the future.

    Customers should discontinue using cartridges labeled with the below
    lot numbers, which were shipped on or after December 17, 2013. The
    affected lots represent approximately 4,746 boxes of cartridges (10
    cartridges per box).

    *Affected Lot Numbers*

    M001963

    	

    M001980

    	

    M002027

    	

    M002083

    	

    M002119

    M001964

    	

    M001987

    	

    M002028

    	

    M002096

    	

    M002120

    M001973

    	

    M001988

    	

    M002029

    	

    M002097

    	


    M001974

    	

    M001990

    	

    M002030

    	

    M002099

    	


    M001979

    	

    M001991

    	

    M002082

    	

    M002100

    	


    All other cartridge lots and the t:slim Insulin Pump are not
    affected by this recall. Customers who received affected cartridges
    are being contacted by the Company or its authorized distributors
    and asked to call Tandem Technical Support to receive replacement
    cartridges at no charge. Tandem expects to have sufficient
    quantities of cartridges to replace affected lots in a timely
    manner. Tandem Customer Support is available 24 hours a day, 7 days
    a week at 1-877-801-6901 <tel:1-877-801-6901>.

    About Tandem Diabetes Care, Inc.

    Tandem Diabetes Care, Inc. is a medical device company with an
    innovative, user-centric and integrated approach to the design,
    development and commercialization of products for people with
    insulin-dependent diabetes. The Company manufactures and sells the
    t:slim Insulin Pump, the slimmest and smallest durable insulin pump
    currently on the market, and the first and only with a high
    resolution, color touch screen. Tandem is based in San Diego, Calif.

    Forward Looking Statement

    This press release includes forward-looking statements concerning
    Tandems voluntary recall of specific lots of cartridges that are
    used with the t:slim. Insulin Pump, the scope of the recall, the
    cause of the potential cartridge leak, the implementation of
    remedial actions that are intended to prevent this issue from
    occurring in the future, and Tandems ability to replace affected
    cartridges on a timely basis. Tandems actual results may differ
    materially from those indicated in these forward looking statements
    due to risks and uncertainties, including: future actions of the FDA
    or any other regulatory body or governmental authority; Tandems
    ability to modify its cartridge manufacturing process in order to
    prevent this issue from occurring in the future; Tandems reliance
    on distributors to facilitate the product recall; the potential that
    Tandem may subsequently discover additional lots of cartridges
    subject to this recall; the possibility that this recall could
    subject Tandem to claims or proceedings which may adversely impact
    its business and financial condition; and other risks identified in
    Tandems Registration Statement on Form S-1. Investors are cautioned
    not to place undue reliance on these forward-looking statements,
    which speak only as of the date of this release. Tandem undertakes
    no obligation to update any forward-looking statement in this press
    release.
.
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