MedComp Recalls CT Port Kits Packaged With Incorrect Needle Size
Medical Components, Inc. is recalling 65 units of CT Port kits that were packaged with 21G needles instead of the labeled 18G needles.
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, but the source text describes a minor labeling/packaging error (incorrect needle size) without reporting any injuries, illnesses, or significant harm, fitting the criteria for a moderate severity score.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 65 units of 6.6F Plastic Dignity Low Profile CT Port kits with Attachable ChronoFlex Polyurethane Catheter. The recall is due to a packaging error where the kits were supplied with a 21G Needle w/Echo Tip, while the product label indicates they contain an 18G Needle w/Echo Tip.
The affected products are identified by Lot # MHGB030 and have an expiration date of July 30, 2020. The distribution pattern for these units includes Arabia, Australia, Israel, Brunei, and Jamaica.
The FDA has classified this as a Class II recall. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of…
- Manufacturer
- Medical Components, Inc dba MedComp
- Affected units
- 65
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 (1)
- Lot # MHGB030 Exp. Date 2020-07-30
Distribution
Distribution scope not specified by the agency.
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