Dignity Mid-Sized CT Port recallZ-1536-2017 · Medical Components, Inc dba MedComp · initiated Feb 23, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Components, Inc dba MedComp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.
Recall details
- Recall number
- Z-1536-2017
- Status
- Terminated
- Initiated by the company
- Feb 23, 2017
- Posted by the FDA
- Mar 8, 2017
- Recalling firm
- Medical Components, Inc dba MedComp
- Quantity
- 71 units
- Product code
- LJT
- FDA submissions
- K132177
- Distribution
- Worldwide Distribution to PR and Panama
Product description
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
Code information (models, lots, serial numbers)
MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dignity® Mid-Sized CT Port MRCTI96801Medical Components, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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