Z-3017-2011

Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion

Name: Z-3017-2011 Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion
Creator: Animas Corporation
Published: 2011-07-29
License: https://open.fda.gov/license/

Animas Corp. / initiated 2011-07-29 / Terminated

FDA source

Animas Corporation began a recall of Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion on 2011-07-29. The reason FDA records is "Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3017-2011
Status: Terminated
Initiated: 2011-07-29
Posted: 2011-08-12
Terminated: 2011-12-07
Recalling firm: Animas Corp.
Product: Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Incorrect component (1nF capacitor) was used to produce 191 printed circuit boards used in six pump lots of which 380 pumps were distributed. This issue may result in the pump displaying a "Replace Battery" alarm not related to the condition of the battery.
FDA root cause: Mixed-up of materials/components
Action: Animas Corporation sent an "Urgent: Insulin Pump Recall" letter dated July, 29 20011 to all affected customers. The letter included affected product and problem. They requested anyone who received the pump to send it back to Animas and a replacement pump will be sent at no charge. For additional information contact the Customer Support Department at (877) 937-7867.
Quantity in commerce: 380
Distribution: Worldwide Distribution: Nationwide (USA) distribution including the states of CA, CO, MA, and MD; and the countries of Australia, Finland, France, Israel, Italy, Sweden and the U.K.
Product codes and lots: Animas 2020 Insulin Pump Serial numbers 00-89133-12, 00-89207-12, 14-88703-12, 14-88710-12, 15-88704-12, 15-89190-12, 16-89096-12, 16-89191-12, 17-88720-12, 17-89097-12, 17-89185-12, 17-89611-12, 18-88721-12, 18-89612-12, 19-88715, 18-89099-12, 19-89187-12, 19-89194-12, 19-89620-12, 20-88716-12, 20-89188-12, 20-89621-12, 21-88717-12, 21-88731-12, 21-89196-12, 21-89615-12, 22-88732-12, 22-89616-12, 23-88733-12, 24-88734-12, 25-88728-12, 25-88735-12, 27-88737-12, 28-88738-12, 33-89824-12, 35-89819-12, 36-89827-12, 88-89100-12, 91-89110-12, 92-89111-12, 93-89112-12, 94-89106-12, 94-89120-12, 95-89107-12, 95-89114-12, 95-89121-12, 96-89115-12, 21-88386-12, 21-88393-12, 22-88387-12, 96-89122-12, 96-89210-12, 97-89116-12, 97-89123-12, 97-89130-12, 01-89215-12, 02-89216-12, 02-89223-12, 02-89230-12, 03-89217-12, 03-89224-12, 03-89400-12, 04-89218-12, 04-89225-12, 04-89232-12, 04-89401-12, 05-89219-12, 05-89226-12, 06-89227-12, 06-89234-12, 06-89241-12, 06-89410-12, 07-89235-12, 07-89242-12, 07-89404-12, 07-89411-12, 08-89236-12, 08-89412-12, 09-89237-12, 09-89406-12, 09-89413-12, 10-89238-12, 10-89414-12, 11-89239-12, 11-89408-12, 11-89415-12, 12-89409-12, 13-89417-12, 14-89418-12, 14-89520-12, 15-89521-12, 17-89509-12, 17-89516-12, 18-89517-12, 18-98524-12, 18-89531-12, 19-89525-12, 29-88672-12, 32-88668-12, 32-88682-12, 20-89533-12, 20-89540-12, 21-88643-12, 21-89541-12, 22-89528-12, 22-89535-12, 22-89542-12, 23-88638-12, 23-88740-12, 24-88741-12, 24-89544-12, 25-88647-12, 26-88655-12, 26-89553-12, 27-88751-12, 27-89385-12, 27-89554-12, 27-89561-12, 28-88745-12, 28-89555-12, 29-88760-12, 29-89556-12, 29-89563-12, 30-88747-12, 30-88754-12, 30-88761-12, 30-89395-12, 31-88755-12, 31-88762-12, 31-89558-12, 32-88756-12, 32-89397-12, 33-88757-12, 33-88771-12, 34-88758-12, 34-88772-12, 35-88759-12, 35-88766-12, 36-88774-12, 37-88768-12, 39-88777-12, 39-88939-12, 41-88948-12, 42-88787-12, 51-88979-12, 03-88414-12, 10-89245-12, 33-88690-12, 40-88697-12, 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24-88646-12, 12-89180-12, 08-88602-12, 11-88605-12, 11-88612-12, 19-88627-12, 21-88629-12, 33-88588-12, 51-88993-12, 54-88989-12, 54-88996-12, 86-89003-12, 89-89013-12, 90-89007-12, 92-89016-12, 97-89028-12, 98-89029-12, 19-88641-12, 27-88656-12, 27-88663-12, 27-88670-12, 29-88658-12, 35-88678-12, 35-88685-12, 36-88679-12, 36-88686-12, 36-88950-12, 37-88951-12, 38-88952-12, 39-88953-12, 40-88947-12, 40-88954-12, 41-88955-12, 42-88949-12, 42-88963-12, 27-88920-12, 30-88923-12, 32-88932-12, 33-88933-12, 34-88927-12, 35-88928-12, 35-88935-12, 18-88802-12, 21-88805-12, 23-88807-12, 33-88838-12, 02-89135-12, 03-89136-12, 04-89144-12, 06-89160-12, 08-89148-12, 11-89077-12, 11-89158-12, 12-89159-12, 12-89173-12, 13-89167-12, 18-89179-12, 23-89293-12, 24-89294-12, 25-89295-12, 00-89126-12, 02-89128-12, 03-89129-12, 13-88702-12, 16-88705-12, 17-88706-12, 99-89125-12, 25-88742-12, 26-88743-12, 27-88744-12, 28-88752-12, 29-88739-12, 29-88746-12, 31-88748-12, 32-88749-12, 32-88763-12, 32-88770-12, 34-88765-12, 35-88773-12, 35-88780-12, 38-88769-12, 38-88776-12, 40-88778-12, 15-88380-12, 16-88374-12, 17-88368-12, 17-88382-12, 18-88369-12, 21-88379-12, 32-88851-12, 42-88868-12, 07-89330-12, 11-89334-12, 19-88803-12, 19-88810-12, 21-88812-12, 22-88820-12, 24-88808-12, 25-88809-12, 25-88816-12, 25-88830-12, 26-88831-12, 27-88818-12, 27-88832-12, 29-88827-12, 29-88834-12, 30-88828-12, 31-88829-12, 31-88836-12, 32-88837-12, 01-89303-12, 02-89142-12, 03-89150-12, 04-89151-12, 05-89138-12, 05-89145-12, 06-89139-12, 07-89161-12, 08-89155-12, 09-89149-12, 09-89156-12, 10-89083-12, 10-89090-12, 10-89157-12, 10-89171-12, 11-89165-12, 13-89174-12, 13-89181-12, 14-89094-12, 14-89168-12, 14-89175-12, 15-89176-12, 20-89276-12, 20-89290-12, 21-89277-12, 21-89291-12, 22-89278-12, 22-89292-12, 25-89288-12, 26-89289-12, 26-89296-12, 27-89297-12, 29-89299-12, 30-88930-12, 12-88701-12, 05-89233-12, 26-88750-12, 37-88775-12, 10-89164-12, 36-88693-12, 39-88696-12, 32-88675-12, 33-88676-12, and 30-88835-12.

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)