Vygon U.S.A.: Medical Device Recall in 2018 - (Recall #: Z-1634-2018)

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:

Neonatal PICC Tray, Product Code: AMS-8010CP-1 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-1634-2018

Event ID: 79752

Reason for Recall:

Potential friction holes may affect the sterility of the product.

Status: Terminated

Product Quantity: 16520 total products

Code Information:

Lot Number: 17C060D UDI: 08498840010563

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