One Touch Ping Insulin Pump using ezManager Max diabetes management software
This recall has been terminated (originally issued May 8, 2010).
- Company
- Animas Corporation
- Recall Initiated
- December 18, 2009
- Posted
- May 8, 2010
- Terminated
- June 22, 2010
- Recall Number
- Z-1560-2010
- Quantity
- 21 pumps
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA
Lot / Code Info
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.
Root 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.