FDA-Device2012-07-04Class II
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
Medical Components, Inc dba MedComp
Hazard
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.
Sold states
Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
Affected count
30
Manufactured in
1499 Delp Dr, Harleysville, PA, United States
Products
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1868-2012Don't want to check this manually?
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