Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1536-2017·Announced 2017-03-29

MedComp Recalls 9.6F CT Ports with Incorrect Introducer Size

Medical Components, Inc. is recalling 71 units of 9.6F CT Ports because they were packaged with 9F introducers instead of the labeled 10F size, preventing proper insertion.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging/labeling error resulting in a device that cannot be inserted, which is a functional defect rather than a direct biological or physical injury hazard, fitting the Moderate criteria for minor labeling/packaging issues.

Plain-English summary

Medical Components, Inc. dba MedComp is recalling 71 units of the 9.6F Plastic Dignity Mid-Sized CT Port with Pre-Attached Silicone Catheter. The recall was initiated because the product kits were packaged with the incorrect valved peelable introducer. Specifically, the product label states that the kit contains a 10F valved peelable introducer, but the kits were actually packaged with a 9F valved peelable introducer.

The size discrepancy creates a functional defect during the insertion procedure. The port lumen will not fit through the 9F introducer, which prevents the device from being inserted as intended. The affected units are identified by the code MRCTI96801, Lot# MHWQ060 S2, and UDI# 884908031232.

The affected products were distributed worldwide to Puerto Rico and Panama. Healthcare providers and patients who have received these specific port kits should stop using them and contact the recalling firm or their medical provider for instructions on replacement or removal.

The recalled product

Product: 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…
Manufacturer: Medical Components, Inc dba MedComp
Category: Medical Device — Implantable Infusion Port
Hazard: mis-labeling
packaging-error
Affected units: 71

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

MRCTI96801 Lot# MHWQ060 S2
UDI# 884908031232

Distribution

Distributed in 1 state:

Same manufacturer · Medical Components, Inc dba MedComp

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Same hazard · mis labeling