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U.S. Department of Health and Human Services

Class 3 Device Recall One Touch Ping Insulin Pump

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 Class 3 Recall
One Touch Ping Insulin Pump
see related information
Date Posted May 08, 2010
Recall Status1 Terminated on June 22, 2010
Recall Number Z-1560-2010
Recall Event ID 54239
Premarket Notification
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, Pennsylvania 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = ANIMAS CORP.
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