Class 2 Device Recall Animas 2020 Insulin Infusion Pump

• Date Initiated by Firm: July 29, 2011
• Date Posted: August 12, 2011
• Recall Status: Terminated on December 07, 2011
• Recall Number: Z-3017-2011
• Recall Event ID: 59517
• Product Classification: Insulin Infusion Pump - Product Code LZG
• Product: Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.
• Code Information: 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.
• FEI Number: 3002920072
• Recalling Firm/ Manufacturer: Animas Corporation; 200 Lawrence Dr; West Chester PA 19380-3428
• For Additional Information Contact: Jon Mulberg; 877-937-7867 Ext. 1257
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.