FDAFDA · Food and drugs·Recall number Z-1868-2012
MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
Published July 4, 2012 · Recall initiated: April 2, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Components, Inc dba MedComp
- Distributor
- Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
- Lot
- Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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