Z-0290-2009

Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood...

Name: Z-0290-2009 Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood...
Creator: Animas Corporation
Published: 2008-08-04
License: https://open.fda.gov/license/

Animas Corp. / initiated 2008-08-04 / Terminated / root cause: manufacturing process

FDA source

Animas Corporation began a recall of Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets on 2008-08-04. The reason FDA records is "Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap...". 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-0290-2009
Status: Terminated
Initiated: 2008-08-04
Posted: 2008-11-25
Terminated: 2010-02-04
Recalling firm: Animas Corp.
Product: Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Unintentional rebooting: Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.
Quantity in commerce: 1,388 caps
Distribution: Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
Product codes and lots: Part Number: 100-158-01. All units (no serial numbers).

Product code LZG

K080639Class IISymphony Glucose Management SystemAnimas Corp. / cleared 2008-06-24

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)