Recall Z-0827-2014— Tandem Diabetes Care Inc

Name: FDA recall Z-0827-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-10

Class I · Terminated

Class I FDA medical device recall by Tandem Diabetes Care Inc, initiated 2014-01-10, terminated 2014-09-23. It names one FDA 510(k) clearance: K111210. Product: T:slim Insulin Delivery System Insulin Infusion Pump. Reason: Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event..

Recalling firm: Tandem Diabetes Care Inc
Classification: Class I
Status: Terminated
Initiated: 2014-01-10
Terminated: 2014-09-23
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111210 — T:SLIM (TM) INSULIN DELIVERY SYSTEMTandem Diabetes Care, Inc.·cleared 2011-11-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

T:slim Insulin Delivery System Insulin Infusion Pump

Reason for recall

Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Data sourced from openFDA. This site is unofficial and independent of the FDA.