| Class 2 Device Recall Animas IR 1200 | |
Date Initiated by Firm | March 18, 2010 |
Date Posted | September 10, 2010 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number | Z-2396-2010 |
Recall Event ID |
55478 |
510(K)Number | K032257 |
Product Classification |
Pump, infusion, insulin - Product Code LZG
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Product | Animas IR 1200
Intended use:deliver insulin therapy |
Code Information |
Serial numbers - see word document in supporting info |
Recalling Firm/ Manufacturer |
Animas Corporation 200 Lawrence Dr West Chester PA 19380-3428
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For Additional Information Contact | Customer Support Department 866-949-1525 |
Manufacturer Reason for Recall | sensor could be damaged |
FDA Determined Cause 2 | 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 professional in those regions. The letters describe the product, problem and action to be taken by the customers. The customers were instructed to follow their User Guide instructions; Pay attention to all pump warnings; NEVER rewind the pump motor, load the insulin cartridge, or prime their infusion set while connected, and fill out the enclosed reply card and send it back to Animas as soon as possible.
Should you have any questions or concerns, please call the Animas Customer Support Department at 1-866-949-1525 or call toll free number on back of pump at 1-877-937-7867. If you are traveling outside of the U.S., please call 610-644-8990 and press option 1. |
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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LZG
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