FDA recall Z-0182-2018

Product

ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Reason for recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Distribution

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

Key facts

Status

Terminated

Initiation date

2017-06-01

Report date

2017-12-06

Termination date

2020-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2018