MedComp Recalls Catheter Repair Kits Due to Connection Failure Risk
Medical Components, Inc. is recalling 93 Catheter Repair Kits because potential connection failures could lead to blood loss or air emboli.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (blood loss or air emboli), which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 93 units of the Catheter Repair Kit, Reference AAC52001, UDI 884908001891. The recall is due to the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines.
The identified hazard is that these connection failures may contribute to blood loss or air emboli. The affected lots are MCFW420, MCDD880, MCDN790, MCCK830, MCCV200, MCCX830, MCDB100, MCDT910, and MCFL210.
The product was distributed worldwide, including nationwide in the United States and in various international locations such as Australia, Canada, and several European countries. The FDA has classified this as a Class II recall. Healthcare facilities and consumers should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Hemodialysis
- Affected units
- 93
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Numbers: MCFW420
- MCDD880
- MCDN790
- MCCK830
- MCCV200
- MCCX830
- MCDB100
- MCDT910 & MCFL210.
Distribution
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
Same manufacturer · Medical Components, Inc dba MedComp
See all →- ModerateMedComp Recalls Power Injectable CT Port Kits with Incorrect Port Size
FDA (Devices) · 2021-03-17
- ModerateMedcomp Titan HD Catheter Kits Recalled for Incorrect Valve Size
FDA (Devices) · 2020-09-16
- SevereMedComp C3 Wave App Recalled Due to ECG Display Failure
FDA (Devices) · 2019-11-06
- ModerateMedComp Recalls Hemodialysis Catheter Kits Due to Introducer Mismatch
FDA (Devices) · 2019-08-14
- ModerateMedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error
FDA (Devices) · 2019-08-14
Same hazard · connection failure
See all →- HighRapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
FDA (Devices) · 2026-07-22
- HighBD Connecta stopcock Port C may over thread rather than tightening
FDA (Devices) · 2026-06-24
- SevereHalyard CATH LAB Kit Due to Syringe Adapter Disconnection Risk
FDA (Devices) · 2026-05-13
- SevereHalyard SAMMC Angiography Kit syringe rotating adapter unwinding recall
FDA (Devices) · 2026-05-13
- SevereHalyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
FDA (Devices) · 2026-05-13