Company:Animas Corp.
Date of Enforcement Report 5/26//2010
Class:lll
PRODUCT
One Touch Ping Insulin Pump using ezManager Max diabetes management software. Recall # Z-1560-2010
REASON
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.
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letter dated December 22, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
