Tandem Diabetes has expanded a recall of insulin cartridges for its t:slim Insulin Pump that run the risk of leaking, the company said in a statement.
Leakage could lead the device to deliver too much or too little insulin, putting patients at risk for serious adverse events, according to the release.
The initial recall was launched on Jan. 10 and involved cartridges that had been distributed since Dec. 17. The expanded recall involves product lot numbers that were shipped before Oct. 16, 2013.
The newly recalled products were discovered in further testing conducted by the company, Tandem said in its press release.
"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," Kim Blickenstaff, CEO of Tandem Diabetes, said in a statement.
A total of about 13,000 boxes of cartridges, with 10 cartridges per box, were affected. Patients can ; affected products will be replaced for free.
Lot numbers not listed weren't affected by the recall, the company said.