MedComp Recalls CT Port Kits Packaged with Incorrect Unmarked Guidewire
Medical Components, Inc. is recalling 8F Plastic Dignity Low Profile CT Port kits because they were packaged with unmarked guidewires instead of the marked ones indicated on the label.
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 and involves a labeling/packaging discrepancy (unmarked vs. marked guidewire) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 24 units of the 8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter. The recall involves Lot # MJKK420, Catalog # MRDP80PLN, with an expiration date of January 9, 2022. The affected units were distributed to locations in California, Arkansas, and Alabama.
The recall was initiated because the kits were packaged with the incorrect guidewire. While the product label indicates that the kit contains a marked guidewire, the recalled units were actually packaged with an unmarked guidewire. This discrepancy between the label and the actual contents constitutes a labeling and packaging error.
Healthcare providers and consumers who possess these specific units should stop using them and contact Medical Components, Inc. for instructions on return or replacement. The agency has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Catheter / Port
- Affected units
- 24
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 (5)
- Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420
- serial # N/A
- Catalog # MRDP80PLN
- Exp. Date 2022-01-09
- UDI#- 884908110449
Distribution
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