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Recall Observatory FDA recall evidence

Device product

MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.

Z-1868-2012

April 02, 2012

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
Event
Event 62238
Status
Terminated
Classification
Class II
Quantity
30
Official record key
device-enforcement:Z-1868-2012

Official wording

Reason: 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.

Code information: Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.