Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
ezManager Max Diabetes Management System version 2.0.9		see related information
Date Posted December 03, 2009
Recall Number Z-0481-2010
Product Animas ezManager Max Diabetes Management System version 2.0.9
Code Information version 2.0.9
Recalling Firm/
Manufacturer		 Animas Corporation
200 Lawrence Dr
West Chester, Pennsylvania 19380-3428
For Additional Information Contact Customer Services
866-423-4087
Reason for
Recall		 Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
Action Animas issued an Urgent Medical Device Correction letter dated 11/2/09 to the pump user and another letter to the health care professional that prescribed the pump. The letters explain the issue. The patient letter is accompanied with a CD that contains the upgraded software and instructions to follow.
Quantity in Commerce 20,648 units
Distribution Nationwide distribution, and Canada, Cayman Islands, and Denmark.
 
-
-