FDA recall Z-2940-2020

Medical Components, Inc dba MedComp · Class II · device

Product

Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

Reason for recall

Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer

Distribution

AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA

Key facts

Status
Terminated
Initiation date
2020-07-27
Report date
2020-09-16
Termination date
2021-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Harleysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2940-2020