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U.S. Department of Health and Human Services

Class 2 Device Recall PICC Tray

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  Class 2 Device Recall PICC Tray see related information
Date Initiated by Firm February 28, 2018
Create Date May 04, 2018
Recall Status1 Terminated 3 on February 19, 2019
Recall Number Z-1637-2018
Recall Event ID 79752
Product Classification Peripheral catheter insertion kit - Product Code OWL
Product PICC Tray, Product Code: AMS-9093CP

Convenience kit for the insertion of PICCs into the vascular system.
Code Information Lot Numbers: 16I026D & 16J032D  UDI: 08498840004784
Recalling Firm/
Vygon U.S.A.
2750 Morris Rd Ste A200
Lansdale PA 19446-6083
For Additional Information Contact Marie Benson
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 16520 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

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.