FDA recall Z-1165-2018

Arrow International Inc · Class II · device

Product

Pressure Injectable Multi- Lumen CVC Kit

Reason for recall

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

Distribution

Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2017-11-14
Report date
2018-03-28
Termination date
2019-07-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1165-2018