FDA recall Z-0256-2018

Terumo Cardiovascular Systems Corporation · Class II · device

Product

TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.

Distribution

Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan

Key facts

Status
Terminated
Initiation date
2017-06-27
Report date
2017-12-27
Termination date
2019-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0256-2018