Recall Z-2396-2010 ยท LZG Pump, Infusion, Insulin
Animas Corporation
Animas IR 1200 Intended use:deliver insulin therapy
| Date | Sep 10, 2010 (initiated Mar 18, 2010) |
| Status | Terminated |
| Reason | sensor could be damaged |
| Root cause | Equipment maintenance |
| Action | An Email was sent by the firm, Animas, to US patients and health care providers where email addresses were on file. Animas sent two "URGENT: MEDICAL DEVICE CORRECTION " letters one dated March 18, 2010, to all US customers, HCPs and distributors of One Touch Ping Glucose Management System and the Animas 2020 Insulin Infusion Pump and the other letter to all US patients, HCPs and distributors of Animas 2020 Insulin Infusion Pump, Animas IR 1200 and Animas IR 1250 (1200 plus). Animas also notified all global distributors and affiliates and sent the letter to customers and health care profession |
| Distribution | Worldwide distribution: USA including states of CA,FL,LA, MA, MI, NY, OH, PA,TX, UT, VA and WA, and countries including Canada, United Kingdom, Finland, Germany, France, Hungary, Puerto Rico, Australia, New Zealand, Israel, Sweden, Czech Republic, Spain, Mexico and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032257 | MODEL IR 1200 INSULIN PUMP Animas Corp., Oct 16, 2003 |