Z-0827-2014Class I

T:slim Insulin Delivery System Insulin Infusion Pump

Name: Z-0827-2014 T:slim Insulin Delivery System Insulin Infusion Pump
Creator: Tandem Diabetes Care Inc
Published: 2014-01-10
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2014-01-10 / Terminated / root cause: manufacturing process

FDA source

Tandem Diabetes Care Inc began a recall of T:slim Insulin Delivery System Insulin Infusion Pump on 2014-01-10. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0827-2014
Classification: Class I
Status: Terminated
Initiated: 2014-01-10
Posted: 2014-02-10
Terminated: 2014-09-23
Recalling firm: Tandem Diabetes Care, Inc.
Product: T:slim Insulin Delivery System Insulin Infusion Pump
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Tandem Diabetes Care sent an Urgent Medical Device Voluntary Recall letter dated January 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check the lot numbers of their cartridge supply against the llist of affected lot numbers. Do Not use any cartridges from the lots affected by this recall. If customers don't have useable cartridges, discontinue using the pump and revert to their backup plan until new supplies arrive. Customers were instructed to call Tandem Technical Support at 1-877-801-6901 to receive replacement cartridges at no charge. Customers were asked to return the enclosed return response form via email, fax, or mail. UPDATED: Tandem Diabetes Care expanded the recall om January 20, 2014. Tandem Diabetes Care, Inc. (NASDAQ: TNDM), or Tandem, today announced that it is expanding a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. For questions regarding this recall calll 858-366-6900, ext 6963.
Quantity in commerce: 12, 807 boxes (10packs)
Distribution: USA (nationwide)
Product codes and lots: Lot Numbers: M000857, M001414, M001454, M001963, M002028, M000869, M001415, M001455, M001964, M002029, M001344, M001416, M001456, M001973, M002030, M001345, M001417, M001457, M001974, M002082, M001346, M001420, M001458, M001979, M002083, M001347, M001421, M001459, M001980, M002096, M001389, M001422, M001460, M001987, M002097, M001390, M001423, M001528, M001988, M002099, M001391, M001451, M001529, M001990, M002100, M001392, M001452, M001530, M001991, M002119, M001393, M001453, M001532, M002027, M002120.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0827-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0827-2014	Class I	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-10

Product code LZG

K111210Class IIT:slim (Tm) Insulin Delivery SystemTandem Diabetes Care, Inc. / cleared 2011-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)