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U.S. Department of Health and Human Services

Class 2 Device Recall Lipogems, Aspiration Cannulae

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  Class 2 Device Recall Lipogems, Aspiration Cannulae see related information
Date Initiated by Firm December 15, 2015
Date Posted January 25, 2016
Recall Status1 Terminated 3 on March 09, 2016
Recall Number Z-0690-2016
Recall Event ID 72904
Product Classification System, suction, lipoplasty - Product Code MUU
Product Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Code Information Ref # AR1318, Lot AB 0643 and AB 0732. Expiration date 04/2020.
Recalling Firm/
Manufacturer		 Globalmed Logistix
1880 Beaver Ridge Cir Ste D
Norcross GA 30071-3833
For Additional Information Contact Robert Turner
404-558-4127
Manufacturer Reason
for Recall		 The cannulae may bend during procedure.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were notified by telephone and letter via FedEx on/about 12/15/2015.
Quantity in Commerce 118 units
Distribution CA, CO, CT, FL, GA, NJ and NY.
Total Product Life Cycle TPLC 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.
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