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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 Device Recall 2.0 mL Cartridge/Syringe Piston component of Insulin Pumpsee related information
Date Initiated by FirmFebruary 25, 2011
Date PostedMay 10, 2011
Recall Status1 Terminated 3 on April 03, 2014
Recall NumberZ-1678-2011
Recall Event ID 58047
510(K)NumberK032257 
Product Classification Pump, infusion, insulin - Product Code LZG
Product2.0 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 PA 19380-3428
For Additional Information ContactJon 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.
FDA Determined
Cause 2		Material/Component Contamination
ActionAnimas 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 Commerce384,180
DistributionWorldwide Distribution - USA (nationwide) and France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LZG
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