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 describe 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, but the source text describes a labeling discrepancy regarding the introducer type without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 6,830 units of 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424. 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, including 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. Specific lot codes associated with the recall include MCAL430, MCAT000, MCBM770, MCBS380, MCCC840, MCCM930, MCCS360, MCCZ450, MCDC580, MCDN120, MCDR420, MCFB350, MCFG980, MCFM410, MCFP230, MCFT430, MCFZ290, MKAF350, MKAG490, MKAM210, MKAR120, MKBA200, MKBL090, MKBL220, MKBV580, MMAB710, MMAM070, and MMAQ950.
Healthcare facilities and consumers should check their inventory for these specific item numbers and lot codes. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA has classified this as a Class II recall.
The recalled product
- Product
- 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 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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