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U.S. Department of Health and Human Services

Class 1 Device Recall Animas(R) 2020 Insulin Infusion Pump

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  Class 1 Device Recall Animas(R) 2020 Insulin Infusion Pump see related information
Date Initiated by Firm January 03, 2013
Date Posting Updated April 03, 2013
Recall Status1 Terminated 3 on May 14, 2015
Recall Number Z-0993-2013
Recall Event ID 64370
510(K)Number K042873  
Product Classification Pump, infusion, insulin - Product Code LZG
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.
Code Information 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-
Recalling Firm/
Manufacturer
Animas Corporation
200 Lawrence Dr
West Chester PA 19380-3428
For Additional Information Contact
610-644-8900
Manufacturer 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.
FDA Determined
Cause 2
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.
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.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = ANIMAS CORP.
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