FDA recall Z-1637-2018

Vygon U.S.A. · Class II · device

Product

PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.

Reason for recall

Potential friction holes may affect the sterility of the product.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-02-28
Report date
2018-05-16
Termination date
2019-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lansdale, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1637-2018