FDA recall Z-1638-2018

Vygon U.S.A. · Class II · device

Product

Maximum Barrier Tray, Product Code: MCITX-1 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-1638-2018