MedComp 8F Plastic Pro-Fuse CT Low Profile Port Recall
Medical Components, Inc. is recalling 30 kits of the MedComp 8F Plastic Pro-Fuse CT Low Profile Port because the kits contain the wrong port model.
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 the hazard involves a labeling/packaging error where the wrong port model is included. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving minor labeling or packaging errors.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 30 units of the MRCTT80041 MedComp 8F Plastic Pro-Fuse CT Low Profile Port with Attachable Chronoflex Polyurethane Catheter. The recall affects kits labeled as an 8F Low Profile Pro-Fuse CT Port that actually contain an 8F Midsize Dignity CT Port. The product was distributed worldwide, including in the United States (nationwide, specifically Georgia and Washington), Ireland, and Turkey.
The recall was initiated because the product was packaged with the incorrect port, causing the contents to not match the label. The agency classified this as a Class II recall. No specific illnesses or injuries are reported in the source text.
Consumers and healthcare providers should stop using the affected kits and contact Medical Components, Inc. for further instructions or a replacement. The affected lot number is MDNK860, with an expiration date of 02/2015.
The recalled product
- Product
- MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
- Manufacturer
- Medical Components, Inc dba MedComp
- Affected units
- 30
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 MRCTT80041
- Lot # MDNK860
- Exp 02/2015
Distribution
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