| Class 3 Device Recall One Touch Ping Insulin Pump | |
Date Initiated by Firm | December 18, 2009 |
Date Posted | May 08, 2010 |
Recall Status1 |
Terminated 3 on June 22, 2010 |
Recall Number | Z-1560-2010 |
Recall Event ID |
54239 |
510(K)Number | K080639 |
Product Classification |
Pump, Infusion, Insulin - Product Code LZG
|
Product | One Touch Ping Insulin Pump using ezManager Max diabetes management software |
Code Information |
Pump serial numbers: 00-72187-15, 00-72194-15, 01-72188-15, 02-72196-15, 04-70673-15, 05-72199-15, 11-70768-15, 18-67503-15, 23-69304-15, 25-66538-15, 30-69170-15, 40-69613-15, 67-69696-15, 75-72201-15, 76-72202-15, 89-71176-15, 90-71177-15, 96-70468-15, 97-72191-15, 98-72192-15, and 99-72193-15. |
Recalling Firm/ Manufacturer |
Animas Corporation 200 Lawrence Dr West Chester PA 19380-3428
|
For Additional Information Contact | Customer Service 866-423-4087 |
Manufacturer Reason for Recall | Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software. |
FDA Determined Cause 2 | Software design |
Action | The recalling firm telephoned the patients/users to inform them of the problem. A letter dated 12/22/09 was also sent to users. Users will have a replacement unit sent to them so that they will be able to fully utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health care provider/prescribing physician for the affected users. |
Quantity in Commerce | 21 pumps |
Distribution | The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA |
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
|
|
|
|