Z-1678-2011

2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion

Name: Z-1678-2011 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
Creator: Animas Corporation
Published: 2011-02-25
License: https://open.fda.gov/license/

Animas Corp. / initiated 2011-02-25 / Terminated / root cause: manufacturing process

FDA source

Animas Corporation began a recall of 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion on 2011-02-25. The reason FDA records is "Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking". 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-1678-2011
Status: Terminated
Initiated: 2011-02-25
Posted: 2011-05-10
Terminated: 2014-04-03
Recalling firm: Animas Corp.
Product: 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Animas Corporation sent an Urgent Recall letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Change their cartridge immediately using the instructions provided. Return all of the unused affected product using the enclosed box. Shipments must be returned using the United States Postal Service. For technical questions call Animas Customer Support at 1-855-254-5668 or call the toll free number at 1-8777-937-7867. For any questions about returning the product call 1-877-280-2339. Customers were instructed to notify the firm by logging on to the following website: www.animasnotification.com or call the Call Center at 1-877-280-2339 if they have no product to return.
Quantity in commerce: 384,180
Distribution: Worldwide Distribution - USA (nationwide) and France.
Product codes and lots: Lot numbers -- US: B201575, B201576, B201581, B201582, Exp. 7/31/2012; B201583, Exp. 8/31/2012; FRANCE: B201580, Exp. 7/31/2012.

Product code LZG

K032257Class IIModel Ir 1200 Insulin PumpAnimas Corp. / cleared 2003-10-16

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)