Z-2395-2010

Animas 2020 Insulin Infusion Pumps

Name: Z-2395-2010 Animas 2020 Insulin Infusion Pumps
Creator: Animas Corporation
Published: 2010-03-18
License: https://open.fda.gov/license/

Animas Corp. / initiated 2010-03-18 / Terminated / root cause: manufacturing process

FDA source

Animas Corporation began a recall of Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapy on 2010-03-18. The reason FDA records is "sensor could be damaged". 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-2395-2010
Status: Terminated
Initiated: 2010-03-18
Posted: 2010-09-10
Terminated: 2010-10-27
Recalling firm: Animas Corp.
Product: Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapy
Product code: LZG Pump, Infusion, Insulin
Reason for recall: sensor could be damaged
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: An Email was sent by the firm, Animas, to US patients and health care providers where email addresses were on file. Animas sent two "URGENT: MEDICAL DEVICE CORRECTION " letters one dated March 18, 2010, to all US customers, HCPs and distributors of One Touch Ping Glucose Management System and the Animas 2020 Insulin Infusion Pump and the other letter to all US patients, HCPs and distributors of Animas 2020 Insulin Infusion Pump, Animas IR 1200 and Animas IR 1250 (1200 plus). Animas also notified all global distributors and affiliates and sent the letter to customers and health care professional in those regions. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow their User Guide instructions; Pay attention to all pump warnings; NEVER rewind the pump motor, load the insulin cartridge, or prime their infusion set while connected, and fill out the enclosed reply card and send it back to Animas as soon as possible. Should you have any questions or concerns, please call the Animas Customer Support Department at 1-866-949-1525 or call toll free number on back of pump at 1-877-937-7867. If you are traveling outside of the U.S., please call 610-644-8990 and press option 1.
Distribution: Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway.
Product codes and lots: Serial numbers - see word document in supporting info

Product code LZG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)