Welcome!

News Feed Item

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, 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.

(Logo: http://photos.prnewswire.com/prnh/20131220/LA37333LOGO)

"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. 

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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Pentaho has announced orchestration capabilities that streamline the entire machine learning workflow and enable teams of data scientists, engineers and analysts to train, tune, test and deploy predictive models. Pentaho’s Data Integration and analytics platform ends the ‘gridlock’ associated with machine learning by enabling smooth team collaboration, maximizing limited data science resources and putting predictive models to work on big data faster – regardless of use case, industry, or languag...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
SYS-CON Events announced today that Addteq will exhibit at SYS-CON's DevOps Summit at Cloud Expo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Addteq specializes in creating innovative solutions to solve business processes through the use of DevOps automation. Addteq was founded on the firm belief that automation is essential for successful software releases. Addteq's products and services are centered around the fundamental approach of understanding the pr...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
Peak 10 has announced that it has completed a 20,000 square foot expansion of its Cincinnati-area data center, a 6,000 square foot expansion of its data center campus in Charlotte’s University Research Park, and added a pair of seasoned executives to its leadership team. This further propels the company on its aggressive growth trajectory to meet the rising demand for flexible hybrid IT strategies and solutions across its enterprise customer base. Cincinnati is home to companies like Kroger, Pr...
VeriStor Systems has announced that CRN has named VeriStor to its 2017 Managed Service Provider (MSP) 500 list in the Elite 150 category. This annual list recognizes North American solution providers with cutting-edge approaches to delivering managed services. Their offerings help companies navigate the complex and ever-changing landscape of IT, improve operational efficiencies, and maximize their return on IT investments. In today’s fast-paced business environments, MSPs play an important role...
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
SYS-CON Events announced today that Infranics will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Since 2000, Infranics has developed SysMaster Suite, which is required for the stable and efficient management of ICT infrastructure. The ICT management solution developed and provided by Infranics continues to add intelligence to the ICT infrastructure through the IMC (Infra Management Cycle) based on mathemat...
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...