Recall Z-1560-2010
Animas Corporation · initiated December 18, 2009
Product
One Touch Ping Insulin Pump using ezManager Max diabetes management software
Codes / lots: 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.
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: Software design
Action taken
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.
Details
- Recall number
- Z-1560-2010
- Initiated
- December 18, 2009
- Posted by FDA
- May 8, 2010
- Terminated
- June 22, 2010
- Product code
- LZG – Pump, Infusion, Insulin
- Quantity
- 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
- Recalling firm
- Animas Corporation, West Chester, PA