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U.S. Department of Health and Human Services

Class 2 Device Recall 7 Microbore Trifurcated Extension Set

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 Class 2 Recall
7 Microbore Trifurcated Extension Set
see related information
Date Posted January 23, 2014
Recall Status1 Terminated on November 03, 2014
Recall Number Z-0813-2014
Recall Event ID 67255
Premarket Notification
510(K) Number
K021395 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Code Information Lot Number: 1306034, 1307011
Recalling Firm/
Manufacturer
Churchill Medical Systems, Inc.
87 Venture Drive
Dover, New Hampshire 03820-5914
Manufacturer Reason
for Recall
Defective component may cause extension sets to leak.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Vygon sent an Urgent Medical Device Recall letter dated January 7, 2014 to each customer via courier service and email. The letter identified the affected product, problem and actions to be taken. The recall letter instructs customers to: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately. 2. Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form 3. Fax or email the form to Vygon including customer contact information. 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number. 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. 6. All inventory will be credited or replaced at no cost to the customer. Distributors were provided with instructions on how to handle product that was further distributed by them. For questions contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by email at customerservice@vygonus.com.
Quantity in Commerce 3850
Distribution US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, 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 = CHURCHILL MEDICAL SYSTEMS, INC.
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