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

Recall number

Z-3017-2011

Recalling firm

Animas Corporation

Product

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

Status

Terminated

Initiated

2011-07-29

Posted

2011-08-12

Terminated

2011-12-07

Reason

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.

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

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.

Lot, serial or model codes

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, 98-89131-12, 14-89256-12, 15-89257-12, 16-89258-12, 17-89273-12, 18-89267-12, 19-89444-12, 20-89269-12, 21-89460-12, 22-88901-12, 22-89461-12, 24-89463-12, 26-88905-12, 27-89466-12, 33-88852-12, 34-88853-12, 35-88854-12, 36-88855-12, 37-88856-12, 39-88872-12, 41-88874-12, 43-88869-12, 47-88887-12, 99-88403-12, 00-88404-12, 00-88411-12, 01-88412-12, 02-88406-12, 02-88413-12, 03-88407-12, 04-88408-12, 04-88415-12, 12-88370-12, 13-88371-12, 14-88372-12, 15-88373-12, 16-88367-12, 16-88381-12, 17-88375-12, 18-88376-12, 18-88383-12, 18-88390-12, 19-88377-12, 19-88384-12, 19-88391-12, 20-88378-12, 20-88385-12, 20-88392-12, 44-88789-12, 00-89140-12, 01-89141-12, 64-83146-12, 00-89221-12, 05-89240-12, 17-89266-12, 22-88394-12, 23-88388-12, 23-88395-12, 24-88389-12, 24-88396-12, 25-88397-12, 26-88398-12, 27-88399-12, 96-88400-12, 99-88410-12, 38-88695-12, 41-88698-12, 09-88603-12, 10-88604-12, 12-88606-12, 12-88613-12, 13-88614-12, 15-88616-12, 22-88637-12, 20-88642-12, 22-88644-12, 23-88645-12, 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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

LZG

Firm FEI

3002920072

Firm city

West Chester

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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