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U.S. Department of Health and Human Services

Class 2 Device Recall THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE

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  Class 2 Device Recall THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE see related information
Date Initiated by Firm May 12, 2015
Date Posted June 15, 2015
Recall Status1 Terminated 3 on April 11, 2016
Recall Number Z-1801-2015
Recall Event ID 71247
510(K)Number K120661  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
Code Information 3103376, 3103377, 3103378, 3524557, 3547157, 3693167, 3843307, 3868998, 3986753, 3991994, 3991995, 3999583, 4011996, 4023525, 4040723, 4040724
Recalling Firm/
Manufacturer		 Vidacare Corporation
4350 Lockhill Selma Rd
Suite 150
Shavano Park TX 78249-2162
For Additional Information Contact Customer Service
855-419-8507
Manufacturer Reason
for Recall		 Potential breach in sterility
FDA Determined
Cause 2		 Device Design
Action Teleflex sent an Urgent Medical Recall Notification dated May 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter directed the customers to quarantine the affected product and return it to the manufacturer. If you have any further questions please call 1-866-246-6990.
Quantity in Commerce 2,104 boxes
Distribution US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
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.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = VIDACARE CORPORATION
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