FDA recall Z-0257-2018

Product

Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477 75478 75104-02 75104-03 75477-01 75037 75973 75308-01 75688 70571-06 75114-01 72755 73306 71180-01 73307 75163 75164 75787 75163-01 73055-02 75450 75451 75452

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-0257-2018