Navigation Links
Tandem Diabetes Care Initiates Voluntary Recall for Specific Lots of Insulin Cartridges Used with t:slim Insulin Pump

SAN DIEGO, Jan. 10, 2014 /PRNewswire/ -- 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 Tandem's 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 NumbersM001963

















M002100All 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. 

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 Tandem's 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 Tandem's ability to replace affected cartridges on a timely basis. Tandem's 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; Tandem's ability to modify its cartridge manufacturing process in order to prevent this issue from occurring in the future; Tandem's 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 Tandem's 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.

SOURCE Tandem Diabetes Care, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Tandem Diabetes Care Announces Closing of Initial Public Offering
2. Tandem Diabetes Care Announces Exercise of Option to Purchase Additional Shares in Initial Public Offering of Common Stock
3. Tandem Diabetes Care Prices Initial Public Offering
5. Tandem Diabetes Care Announces FDA Clearance of t:connect Diabetes Management Application for Use with t:slim Insulin Pump
6. Tandem Diabetes Care Names Lonnie Smith As Chairman Of The Board
7. Data Demonstrating the Safety and Efficacy of Chimerixs Antiviral CMX001 Presented at BMT Tandem Meetings
8. Data Related to Chimerixs Antiviral CMX001 to be Presented in Three Poster Sessions at the BMT Tandem Meetings
9. Tandem Diabetes Care Acquires Select Patents and Patent Applications from Smiths Medical
10. Lilly Diabetes to contribute $200,000 to the Diabetes Scholars Foundation
11. Chewable Tablet Might Offer New Help for Diabetes Patients
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... 23, 2016  MedSource announced today that it ... software solution of choice.  This latest decision demonstrates ... to their clients by offering a state-of-the-art electronic ... establishes nowEDC as the EDC platform of choice ... clients.  "nowEDC has long been a preferred EDC ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... ... Scientific Sessions in Dallas that it will receive two significant new grants to ... came as PHA marked its 25th anniversary by recognizing patients, medical professionals and ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all ... brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its ... Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding ... Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, we ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions ... initiated cultivation and processing operations at its production facility, and opened its first ... is the manufacturer of a complete system of proactive air and surface purification ...
Breaking Medicine News(10 mins):