Z-0993-2013Class I

Animas(R) 2020 Insulin Infusion Pump

Name: Z-0993-2013 Animas(R) 2020 Insulin Infusion Pump
Creator: Animas Corporation
Published: 2013-01-03
License: https://open.fda.gov/license/

Animas Corp. / initiated 2013-01-03 / Terminated / root cause: manufacturing process

FDA source

Animas Corporation began a recall of Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of... on 2013-01-03. FDA classified it as Class I and gives the reason as "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...". 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-0993-2013
Classification: Class I
Status: Terminated
Initiated: 2013-01-03
Posted: 2013-04-03
Terminated: 2015-05-14
Recalling firm: Animas Corp.
Product: 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.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 7,157 (494 US pumps affected)
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0993-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0993-2013	Class I	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-03

Product code LZG

K042873Class IIAnimas Model Ir1250 Insulin Infusion PumpAnimas Corp. / cleared 2004-12-10

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)