FDA recall Z-0657-2018
Arrow International Inc · Class II · device
Product
Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
Reason for recall
These finished good kits may contain the incorrect Springwire Guide (SWG).
Distribution
Distribution US Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-10-17
- Report date
- 2018-02-28
- Termination date
- 2020-04-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Reading, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0657-2018