Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
This recall has been terminated (originally issued April 3, 2013).
- Company
- Animas Corporation
- Recall Initiated
- January 3, 2013
- Posted
- April 3, 2013
- Terminated
- May 14, 2015
- Recall Number
- Z-0993-2013
- Quantity
- 7,157 (494 US pumps affected)
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.
Distribution
Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Puerto Rico and the countries of: Australia, Austria, Bermuda, Canada, Czech Republic, Finland, France, Germany, Ireland, Israel, Italy, Mexico, New Zealand, Norway, Spain and the United Kingdom.
Lot / Code Info
Part Numbers 101370-00, 101371-00, 101372-00, 101374-00, 101375-00, 100380-00, 100381-00, 100382-00, 100384-00, and 100385-00. Serial Numbers: 62-00202-12 36-97839-12 01-05118-12 25-02849-12 63-99894-12 80-00093-12 37-04692-12 92-04130-12 27-99281-12 32-99198-12 81-00513-12 44-02998-12 46-99680-12 23-02928-12 03-04500-12 01-03079-12 79-00261-12 26-99273-12 16-03650-12 93-03219-12 12-02808-12 21-04715-12 34-98485-12 40-98917-12 19-03646-12 27-00988-12 09-02900-12 28-99437-12 96-05032-12 03-00908-12 25-98448-12 15-02913-12 33-99713-12 91-00632-12 71-01130-12 07-05064-12 15-00948-12 92-02246-12 36-98399-12 97-00740-12 75-00229-12 32-01986-12 80-02118-12 97-04135-12 26-00899-12 20-03654-12 44-99495-12 31-99285-12 23-01970-12 43-99575-12 48-99499-12 83-00191-12 11-00768-12 31-99461-12 88-02066-12 88-00189-12 34-02974-12 24-02950-12 54-99790-12 96-03067-12 91-04122-12 74-00235-12 23-02759-12 96-04127-12 11-02652-12 44-99488-12 09-00766-12 23-03569-12 99-00580-12 20-02918-12 12-04178-12 06-05063-12 75-00243-12 29-02874-12 96-00549-12 75-00074-12 76-02114-12 03-00739-12 04-04237-12 76-03005-12 99-00559-12 01-03086-12 32-99374-12 97-03244-12 97-02346-12 90-02251-12 94-02343-12 43-99818-12 07-00838-12 19-02850-12 77-00083-12 90-02075-12 21-01961-12 88-04200-12 90-03061-12 10-00767-12 33-02885-12 16-98520-12 05-02294-12 70-00231-12 58-01001-12 34-04682-12 10-04190-12 64-00204-12 96-03081-12 35-02982-12 02-00488-12 18-98508-12 82-00088-12 01-00649-12 26-02938-12 22-04716-12 11-03624-12 14-98511-12 95-03066-12 28-98553-12 00-05029-12 95-05031-12 08-98403-12 36-02990-12 24-04718-12 03-02278-12 92-00707-12 20-02932-12 49-99933-12 10-99215-12 35-98567-12 36-97853-12 10-02394-12 03-02609-12 76-01054-12 77-00245-12 09-02555-12 00-02532-12 25-02944-12 06-00844-12 25-02782-12 19-02917-12 39-02898-12 37-99481-12 25-03754-12 95-02351-12 33-99449-12 78-00239-12 20-00879-12 22-98526-12 39-98916-12 33-98389-12 12-99224-12 52-99679-12 17-02908-12 51-99678-12 05-05055-12 26-04572-12 24-99271-12 25-02937-12 32-01979-12 83-00089-12 13-98422-12 97-04128-12 06-04503-12 80-02051-12 18-99501-12 07-98402-12 84-02048-12 14-00873-12 56-00101-12 14-04701-12 55-00100-12 35-04683-12 56-04996-12 69-00216-12 18-02909-12 81-03024-12 02-04404-12 16-00699-12 51-99773-12 31-02883-12 11-98413-12 99-02281-12 20-04471-12 00-03342-12 01-00744-12 79-00078-12 39-04694-12 94-02350-12 41-99485-12 13-02647-12 75-01046-12 89-02250-12 20-04721-12 93-02247-12 37-97854-12 74-01133-12 96-00644-12 30-98562-12 23-99175-12 37-98488-12 15-99227-12 33-98910-12 39-04687-12 91-04210-12 51-98949-12 78-00091-12 11-03617-12 95-03080-12 03-00841-12 74-03003-12 04-00909-12 06-00763-12 21-00894-12 16-01942-12 16-99242-12 80-02301-12 08-00846-12 21-99504-12 07-99050-12 36-03948-12 28-04486-12 30-99460-12 66-99897-12 99-03077-12 23-00984-12 08-00765-12 95-00724-12 02-02284-12 28-98560-12 06-02390-12 21-03648-12 15-02818-12 15-02832-12 98-04143-12 82-03113-12 52-98890-12 97-02522-12 39-02986-12 34-03865-12 03-05060-12 09-00847-12 12-98421-12 26-00987-12 11-98420-12 19-98530-12 12-02396-12 86-02057-12 16-03636-12 73-00234-12 25-00986-12 96-02521-12 10-99208-12 88-02228-12 40-04688-12 57-01000-12 87-00702-12 21-00982-12 40-99565-12 28-98546-12 30-00998-12 07-05057-12 87-00195-12 75-01127-12 27-98538-12 60-01003-12 30-99284-12 03-00760-12 01-02364-12 05-04171-12 56-99697-12 92-02341-12 59-01002-12 12-02910-12 87-03125-12 18-03645-12 44-99833-12 99-05035-12 48-98696-12 29-02962-12 41-04689-12 89-04018-12 79-01138-12 01-02276-12 93-04117-12 09-05080-12 32-04497-12 34-99471-12 07-00926-12 07-99205-12 45-97869-12 98-05034-12 19-02829-12 02-02365-12 47-99829-12 99-02612-12 06-00837-12 20-98605-12 89-04120-12 71-00218-12 63-00210-12 39-99476-12 02-02622-12 22-00983-12 20-04383-12 07-02715-12 20-00893-12 86-00099-12 85-00362-12 16-98513-12 13-02485-12 26-98706-12 37-04685-12 22-99262-12 63-01006-12 04-02543-12 34-01995-12 83-03019-12 99-05042-12 79-02300-12 14-04606-12 34-02981-12 86-02307-12 06-99028-12 21-04722-12 11-01666-12 07-04166-12 76-01128-12 33-99463-12 29-02881-12 37-99900-12 82-00190-12 62-99886-12 23-02942-12 33-04917-12 84-00097-12 96-02352-12 14-02912-12 13-03721-12 09-02643-12 18-03652-12 00-04226-12 31-98725-12 16-02914-12 15-98505-12 19-99502-12 29-02948-12 36-02888-12 92-00538-12 03-02366-12 22-02927-12 32-99279-12 23-00991-12 95-00629-12 64-99895-12 05-02368-12 71-00232-12 28-98539-12 23-03657-12 10-00848-12 98-00646-12 05-00836-12 09-03358-12 10-02299-12 77-01129-12 85-00700-12 26-02783-12 02-00840-12 29-00997-12 11-04184-12 02-05052-12 35-02887-12 49-97975-12 31-04489-12 26-04477-12 00-05050-12 72-00233-12 40-03885-12 92-00633-12 14-01852-12 09-99207-12 03-00746-12 15-03716-12 33-04498-12 38-99475-12 95-02344-12 21-04472-12 25-04726-12 99-02355-12 63-99799-12 96-02345-12 04-04406-12 38-03890-12 27-99362-12 35-99296-12 94-04125-12 96-02271-12 37-02984-12 13-02911-12 34-99376-12 10-00693-12 19-04470-12 97-02353-12 37-99562-12 94-02248-12 37-99805-12 11-99135-12 97-02339-12 96-00563-12 40-99491-12 16-04608-12 29-02793-12 03-99106-12 08-03621-12 68-00215-12 01-01642-12 40-99477-12 88-00710-12 17-02760-12 56-05982-12 25-98712-12 95-02520-12 38-98489-12 94-00723-12 13-03626-12 29-98547-12 90-00712-12 26-01980-12 00-00581-12 71-01123-12 18-04374-12 29-04487-12 30-99189-12 22-03656-12 04-05054-12 40-98593-12 12-02653-12 58-99787-12 31-03950-12 99-00566-12 11-99061-12 04-04156-12 82-00271-12 23-03738-12 17-02922-12 21-98606-12 26-99266-12 62-99798-12 11-00937-12 22-04473-12 26-03586-12 20-04369-12 19-98509-12 94-00730-12 34-04499-12 08-02392-12 01-03343-12 35-98398-12 19-05097-12 08-00839-12 28-98391-12 07-00764-12 41-03893-12 16-04372-12 47-04980-12 10-00929-12 01-00832-12 58-99794-12 14-02648-12 23-04717-12 04-01645-12 23-02861-12 91-02245-12 22-02691-12 20-02851-12 40-03878-12 06-02369-12 98-02611-12 78-00084-12 22-02846-12 09-04168-12 00-02356-12 15-00874-12 09-00692-12 92-00552-12 44-98597-12 08-00934-12 13-04700-12 05-01727-12 69-00304-12 32-02965-12 06-05056-12 31-98563-12 07-04159-12 80-00079-12 04-05061-12 40-98498-12
Root Cause
Nonconforming Material/Component
Action Taken
Animas sent an Urgent Recall letter dated December 17, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that Animas will send a replacement pump free of charge, along with instructions for returning their pump. For questions or concerns contact at 866-796-6373.