MedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size
Medical Components, Inc. is recalling 96 Power Injectable CT Port kits because they contain 6.6F ports instead of the correct 5F size, which may prolong surgical procedures.
What this means for you
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 involves a procedural delay that increases surgical risk, but the source text does not report any specific injuries, hospitalizations, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 96 Power Injectable CT Port insertion kits (Catalog Number: MRDP50AXS, Lot Numbers: MPDX180 and MPCY660). The recall was initiated because the kits were packaged with the incorrect size port. Specifically, the kits include a 6.6F port instead of the correct 5F port.
The incorrect port size may prevent the catheter lumen from connecting to the port stem. This issue might not be discovered until the catheter lumen is already placed in the vessel, requiring the surgeon to obtain an alternate port. This error prolongs the insertion procedure, which increases the risks associated with any surgical procedure.
The affected products were distributed nationwide in California, the District of Columbia, Georgia, Illinois, Indiana, Massachusetts, Michigan, New Jersey, New Mexico, New York, Ohio, Pennsylvania, and Texas. Healthcare providers and patients should stop using these specific kits and contact the manufacturer for replacement or further instructions.
The recalled product
- Product
- Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
- Manufacturer
- Medical Components, Inc dba MedComp
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 (3)
- Catalog Number: MRDP50AXS
- Lot Number: MPDX180
- UDI Number: 884908149753 (updated 3/11/2021 added lot number: MPCY660)
Distribution
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