Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2216-2019·Announced 2019-08-14

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.

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, 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
Category: Medical Device — Hemodialysis Catheter
Hazard: mis-labeling
Affected units: 6,830

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

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.

See all 3 products in this recall →

Same manufacturer · Medical Components, Inc dba MedComp

See all →

Moderate
MedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size
FDA (Devices) · 2021-03-17
Moderate
Medcomp Titan HD Catheter Kits Recalled for Incorrect Valve Size
FDA (Devices) · 2020-09-16
Severe
MedComp C3 Wave App Recalled Due to ECG Display Failure
FDA (Devices) · 2019-11-06
Moderate
MedComp Recalls Hemodialysis Catheter Kits Due to Introducer Mismatch
FDA (Devices) · 2019-08-14
Moderate
MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error
FDA (Devices) · 2019-08-14

Same hazard · mis labeling