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U.S. Department of Health and Human Services

Class 2 Device Recall Churchill Medical Systems 22Ga Winged Infusion Set

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 Class 2 Recall
Churchill Medical Systems 22Ga Winged Infusion Set
see related information
Date Posted May 01, 2012
Recall Status1 Terminated on March 28, 2013
Recall Number Z-1480-2012
Recall Event ID 61653
Premarket Notification
510(K) Number
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set Product Code: MBS-2210 Huber type needle set used for the infusion of medical fluids into implantable ports.
Code Information Lot Number: 1202077
Recalling Firm/
Churchill Medical Systems, Inc.
87 Venture Drive
Dover, New Hampshire 03820-5914
Manufacturer Reason
for Recall
Mislabeled: MBS-2210 code on case label -22Ga Winged Infusion Set, ; however, the product label states 20Ga MBS-2010 code listed on device label.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action The firm, VYGON, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 16, 2012 to its customers via overnight, courier service. The letter described the product, problem and actions to be taken. The customers were instructed to check their stock for the products included within the scope of the recall; count and document their affected inventory; contact Vygon's Customer Service Department at 1-800-473-5414 for return merchandise authorization number; return the affected product; complete and immediately return the Acknowledgement and Inventory Return Form via fax to 215-672-6740 and send the original form with their shipment . Distributors were instructed to communicate this recall to their customers and provide them with the Acknowledgement and Inventory Return Form for completion and return. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@yygonus.com.
Quantity in Commerce 552 units
Distribution Worldwide distribution: USA (nationwide) including states of: IN, KS, KY, NY,MA, MI , and TX; and country of: Canada.
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 = FMI and Original Applicant = ADVANTAGE MEDICAL SYSTEMS, INC.