MedComp Two Part Adapter Recall for Potential Connection Failures
Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause 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 involves a medical device with a potential for serious injury (blood loss or air emboli) and is classified as FDA Class II, which aligns with the 'Severe' criteria for significant injury risks.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 35 units of the Two Part Adapter (Ref MCTLA2000, UDI 884908027310). The product is a repair kit indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
The recall is being issued because there is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines. These failures may contribute to blood loss or air emboli.
The affected lots are MCFF700, MCFB160, MKAG11O, MCDP590, MCDS140, and MCFSOSO. The products were distributed worldwide, including in the United States and various international locations. Users should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 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
- Affected units
- 35
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 (5)
- Lot Numbers: MCFF700
- MCFB160
- MKAG11O
- MCDP590
- MCDS140 & MCFSOSO
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