FDA-Device2020-09-16Class II

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

Medical Components, Inc dba MedComp
Hazard

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

Sold states
AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA
Affected count
132 eaches
Manufactured in
1499 Delp Dr, Harleysville, PA, United States
Products
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

Official notice

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

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