Tandem Diabetes Care recently announced that it is expanding a voluntary recall of specific lots of insulin cartridges used with its t:slim insulin pump.
The affected cartridges, about 130,000 shipped in 13,000 boxes, may be at risk for leaking, potentially causing the t:slim to deliver too much or too little insulin, Tandem announced in a Monday news release.
|Approximately 130,000 T:slim cartridges could be at risk for leaking.|
The device not delivering the correct insulin dosage could lead to a serious adverse event for a user. Tandem first announced the recall on Jan. 10, with affected lots shipped between December 17, 2013 to January 10, 2014. The Monday announcement expands the recall to lots shipped before October 16, 2013.
“The safety of our customers is our top priority. For that reason, even after our previous announcement Tandem’s team continued to perform further testing. Based on this work we recognized that additional cartridge lots could also be at risk for leaking and so we are expanding the scope of this recall,” says Kim Blickenstaff, president and CEO of San Diego–based Tandem. “We are confident that we have identified all of the affected cartridge lots that may have been shipped to customers or distributors and that we have implemented appropriate corrective actions to prevent this from happening in the future.”
|Check out the conference track on risk, quality, and validation from February 10 through 13 at MD&M West in Anaheim, CA.|
Cleared by the FDA in late 2011, the t:slim was the first insulin pump to have a color touch screen and sported a design considered "Apple-esque." When it debuted, the device, which has the footprint of a credit card, was 25% smaller than competing products.
- Five Mistakes That Can Derail Your Product Development Effort - Webcast
- How to Manage Risk Throughout Medical Device Product Development Cycle and Beyond - Webcast
- Common Mistakes to Avoid During Medical Device Product Development - Webcast
- BIOMED Boston - Event
- MD&M West - Event
- Build (or Fix) Your Quality Management System - Webcast