| Class 2 Device Recall PICC Insertion Tray | |
Date Initiated by Firm | February 28, 2018 |
Create Date | May 04, 2018 |
Recall Status1 |
Terminated 3 on February 19, 2019 |
Recall Number | Z-1639-2018 |
Recall Event ID |
79752 |
Product Classification |
Peripheral catheter insertion kit - Product Code OWL
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Product | PICC Insertion Tray, Product Code: AMS-7192CS-3
Convenience kit for the insertion of PICCs into the vascular system. |
Code Information |
Lot Numbers: 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, 17H041D, UDI: 08498840009765 |
Recalling Firm/ Manufacturer |
Vygon U.S.A. 2750 Morris Rd Ste A200 Lansdale PA 19446-6083
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For Additional Information Contact | Marie Benson 800-473-5414 |
Manufacturer Reason for Recall | Potential friction holes may affect the sterility of the product. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm, Vygon USA, mailed an "URGENT MEDICAL DEVICE RECALL" letter dated 2/28/2018 to affected customers. The letter described the product, problem and actions to be taken. The Customers are instructed 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) complete and return form via Fax to 215-672-6740 or email to: customerservice@vygonus.com 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.
Distributors are instructed to: communicate the recall to customers who received the affected product by providing them a copy of the notification. Also, provide a copy of the Recall Acknowledgement and Inventory Return Form to customers.
If you have questions or concerns please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com. |
Quantity in Commerce | 16,520 total products |
Distribution | Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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