Vygon U.S.A.: Medical Device Recall in 2018 - (Recall #: Z-1639-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.

Product Classification:

Class II

Date Initiated: February 28, 2018

Date Posted: May 16, 2018

Recall Number: Z-1639-2018

Event ID: 79752

Reason for Recall:

Potential friction holes may affect the sterility of the product.

Status: Terminated

Product Quantity: 16,520 total products

Code Information:

Lot Numbers: 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, 17H041D, UDI: 08498840009765

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated