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U.S. Department of Health and Human Services

Class 2 Device Recall 2.0 mL Cartridge/Syringe Piston component of Insulin Pump

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 Class 2 Recall
2.0 mL Cartridge/Syringe Piston component of Insulin Pump
see related information
Date Posted May 10, 2011
Recall Status1 Open
Recall Number Z-1678-2011
Recall Event ID 58047
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product 2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
Code Information Lot numbers -- US: B201575, B201576, B201581, B201582, Exp. 7/31/2012; B201583, Exp. 8/31/2012; FRANCE: B201580, Exp. 7/31/2012.
Recalling Firm/
Manufacturer
Animas Corporation
200 Lawrence Dr
West Chester, Pennsylvania 19380-3428
For Additional Information Contact Jon Mulberg
408-942-5937
Manufacturer Reason
for Recall
Action is being undertaken to address the occurrence of adverse events associated with leaking cartridges. Firm became aware of this issue through customer complaints from pump users reporting the cartridges were leaking.
Action Animas Corporation sent an Urgent Recall letter dated February 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Change their cartridge immediately using the instructions provided. Return all of the unused affected product using the enclosed box. Shipments must be returned using the United States Postal Service. For technical questions call Animas Customer Support at 1-855-254-5668 or call the toll free number at 1-8777-937-7867. For any questions about returning the product call 1-877-280-2339. Customers were instructed to notify the firm by logging on to the following website: www.animasnotification.com or call the Call Center at 1-877-280-2339 if they have no product to return.
Quantity in Commerce 384,180
Distribution Worldwide Distribution - USA (nationwide) and France.
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
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