Agency classClass IIOur severity:Severe FDA (Devices)·Z-1125-2018·Announced 2018-03-28

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category: Medical Device — Hemodialysis Accessories
Hazard: connection-failure
blood-loss
air-emboli
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

Distributed nationwide across the United States.

The notice also names 34 states specifically:

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 →

Same manufacturer · Medical Components, Inc dba MedComp

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Same hazard · connection failure