FDA recall Z-0837-2020

Arrow International Inc · Class II · device

Product

Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH

Reason for recall

Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.

Distribution

US: FL

Key facts

Status
Terminated
Initiation date
2019-12-06
Report date
2020-01-29
Termination date
2021-11-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0837-2020