Agency classClass IIOur severity:Severe FDA (Devices)·Z-1123-2018·Announced 2018-03-28

MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures

Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures 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), which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.

Plain-English summary

Medical Components, Inc. dba MedComp is recalling 40 kits of 12F Modified Tesio Catheter Sets (Reference MCTC1235SM, UDI 884908027259). The affected lots are MCBM830, MCDZ620, and MCDP130. The product is indicated for use in replacing damaged female luer connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.

The recall was initiated because there is a 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 products were distributed worldwide, including nationwide in the United States and in several international countries such as Australia, Canada, France, Germany, and the United Kingdom. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product: 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 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 — Catheter
Hazard: blood-loss
air-emboli
connection-failure
Affected units: 40

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 (2)

Lot Numbers: MCBM830
MCDZ620 & MCDP130.

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 · blood loss