MedComp Recalls Hemodialysis Catheter Kits Due to Introducer Mismatch
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
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, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding the introducer type, which fits the criteria for a moderate severity labeling issue.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 6,830 units of 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423. 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 the states of 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 covers specific lot codes including MCAK580, MCAS990, MCAY850, and others listed in the agency record.
Consumers and healthcare facilities should stop using these kits and contact Medical Components, Inc. for further instructions or a replacement. This recall addresses a labeling discrepancy regarding the specific type of introducer included in the kit.
The recalled product
- Product
- 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
- Manufacturer
- Medical Components, Inc dba MedComp
- 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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