Class 2 Device Recall AMS636, 60" Microbore extension set.

• Date Initiated by Firm: February 20, 2017
• Create Date: March 18, 2017
• Recall Status: Terminated on April 22, 2019
• Recall Number: Z-1484-2017
• Recall Event ID: 76607
• 510(K)Number: K021395
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: AMS-636, 60" Microbore extension set.; ; Product Usage:; Accessory devices used to administer medical fluids.
• Code Information: 1610092D 1611091D 1612068D 1612074D
• 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 printed on the device package.
• FDA Determined Cause: Error in labeling
• Action: Recall letters were sent to the customer via email and fax on 2/20/2017. They were asked to take the following actions: The recall will be conducted at no cost to you. To effect return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 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. If you have questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-4 73-5414, or by e-mail at customerservice@vygonus.com.
• Quantity in Commerce: 30,700
• Distribution: US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
• 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.