FDA recall Z-0536-2018

Product

PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.

Reason for recall

Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.

Distribution

Distribution US nationwide.

Key facts

Status

Terminated

Initiation date

2017-12-28

Report date

2018-02-14

Termination date

2021-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0536-2018