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U.S. Department of Health and Human Services

Class 2 Device Recall Vygon

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  Class 2 Device Recall Vygon see related information
Date Initiated by Firm November 18, 2016
Create Date December 18, 2016
Recall Status1 Terminated 3 on October 23, 2017
Recall Number Z-0787-2017
Recall Event ID 75816
510(K)Number K021395  
Product Classification Set, administration, intravascular - Product Code FPA
Product AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651

Product Usage:
Accessory devices used to administer medical fluids.
Code Information 1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D
Recalling Firm/
Manufacturer		 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
87 Venture Dr
Dover NH 03820-5914
For Additional Information Contact
800-473-5414
Manufacturer Reason
for Recall		 Incorrect priming volume is printed on the device package.
FDA Determined
Cause 2		 Device Design
Action Vygon sent an Urgent Medical Device Recall letter dated November 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to take the following actions: 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 you. For questions contact local sales representative or Vygon's Customer Service Department at 1-800-473-5414.or by email at customerservice@vygonus.com.
Quantity in Commerce 31,500
Distribution US distribution in the state of CA
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 = FPA and Original Applicant = CHURCHILL MEDICAL SYSTEMS, INC.
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