9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1536-2017.
The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1536-2017.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medical Components, Inc Dba Medcomp or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1536-2017.
Medical Components, Inc dba MedComp
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Medical Components, Inc Dba Medcomp Recall FAQ
Medical Components, Inc Dba Medcomp is the subject of a medical implants safety report: 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated.... The notice was published on February 23, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 71 units are potentially affected.