Maximum Barrier Tray, Product Code: MCITX-1 recallZ-1638-2018 · Vygon U.S.A. · initiated Feb 28, 2018

Why it was recalled

Potential friction holes may affect the sterility of the product.

FDA root cause category: Under Investigation by firm

What the company is doing

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: [email protected] 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 [email protected].

Recall details

Recall number

Z-1638-2018

Status

Terminated

Initiated by the company

Feb 28, 2018

Recalling firm

Vygon U.S.A.

Quantity

16,520 total products

Product code

OWL

Distribution

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Product description

Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• MCI MCITX-1

  Vygon Corporation · Peripheral catheter insertion kit
  1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 79752).

• Z-1633-2018 · Terminated
  PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
• Z-1634-2018 · Terminated
  Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
• Z-1635-2018 · Terminated
  Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
• Z-1636-2018 · Terminated
  Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
• Z-1637-2018 · Terminated
  PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
• Z-1639-2018 · Terminated
  PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
• Z-1640-2018 · Terminated
  PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.