Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1149-2019·Announced 2019-04-24

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 when it is non-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 due to a labeling error regarding the type of introducer included. The rubric assigns a score of 2 (Moderate) to minor labeling errors and voluntary precautionary recalls where no specific injury or illness is reported.

Plain-English summary

Medical Components, Inc. dba MedComp is recalling 6,830 units of 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422. The recall was initiated because the tray labels indicate that 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 to accounts 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 MCAL680, MCBA840, MCBH140, MCBK600, MCBY920, MCCH670, MCCR320, MCCV590, MCDG930, MCDK980, MCDR400, MCFB320, MCFG490, MCFR460, MCFT410, MCFY850, MCFZ660, MKAD410, MKAN270, MKAP300, MKAT100, MKAX320, MKBA190, MKBK940, MKBL210, MKBP450, MKBV570, MMAA170, MMAD480, and MMAS020.

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, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Manufacturer: Medical Components, Inc dba MedComp
Category: Medical Device — Catheter
Hazard: mis-labeling
Affected units: 6,830

Distribution

Distributed in 20 states:

Same manufacturer · Medical Components, Inc dba MedComp

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Same hazard · mis labeling