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U.S. Department of Health and Human Services

Class 2 Device Recall Lifeguard Infusion Set with Smartsite, 20Ga, 1

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 Class 2 Recall
Lifeguard Infusion Set with Smartsite, 20Ga, 1
see related information
Date Posted March 06, 2013
Recall Status1 Terminated on September 10, 2013
Recall Number Z-0914-2013
Recall Event ID 64464
Premarket Notification
510(K) Number
K013871 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Code Information Lot #1210099
Recalling Firm/
Manufacturer
Churchill Medical Systems, Inc.
87 Venture Drive
Dover, New Hampshire 03820-5914
Manufacturer Reason
for Recall
The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Vycon sent an Urgent Medical Device Recall letter dated January 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed check their stock for the affected product and immediately cease use and distribution and quarantine all affected product immediately. Count and document their affected inventory on the Recall Acknowledgement and Inventory Return Form. Customers were instructed to fax or email the form to Vygon including customer contact information. All affected product would be credited or replaced at no cost to the customer. Customers with questions were instructed to call 1-800-473-5414, or by e-mail at customerservice@vygonus.com. For questions regarding this recall call 603-743-5988.
Quantity in Commerce 2340
Distribution Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.
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 = FPA and Original Applicant = HORIZON MEDICAL PRODUCTS, INC.
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