MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
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 error regarding the type of introducer included, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 6,830 units of 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425. The recall was initiated because the tray labels indicate the kits are packaged with a 15F "valved" peelable introducer, but the kits actually contain a 15F "non-valved" peelable introducer.
The affected products were distributed nationwide in the United States, specifically in California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and West Virginia. The recall includes specific lot codes such as MCAM240, MCBL480, and MCBS870.
Healthcare facilities and consumers should stop using these kits and contact Medical Components, Inc. for further instructions. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 6,830
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medical Components, Inc dba MedComp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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