Date Initiated by Firm |
January 07, 2014 |
Date Posted |
January 23, 2014 |
Recall Status1 |
Terminated 3 on November 03, 2014 |
Recall Number |
Z-0813-2014 |
Recall Event ID |
67255 |
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 NH 03820-5914
|
For Additional Information Contact |
800-473-5414
|
Manufacturer Reason for Recall |
Defective component may cause extension sets to leak.
|
FDA Determined Cause 2 |
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 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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