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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 September 24, 2019
Create Date November 27, 2019
Recall Status1 Terminated 3 on October 21, 2020
Recall Number Z-0585-2020
Recall Event ID 84010
510(K)Number K181208  
Product Classification Midline catheter - Product Code PND
Product 4Fr x 20cm Single Lumen CT
Midline Basic Tray, Product Code: VYML4S1001
Code Information Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
Recalling Firm/
Manufacturer		 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
87 Venture Dr
Dover NH 03820-5914
Manufacturer Reason
for Recall		 Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
FDA Determined
Cause 2		 Packaging process control
Action On September 25, 2019 the firm distributed Urgent Medical Device Recall Communication letters by e-mail instructing them 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 in Attachment 1. Please complete and return the document even if you currently have no product on hand. 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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions, please contact your local sales representative or Vygons Customer Service Department at 1-800-473-5414 Monday-Friday 8am  6pm, or by e-mail at customerservice@vygonus.com.
Quantity in Commerce 75
Distribution One Customer Located in TN
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 = PND and Original Applicant = Vygon USA
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