Agency classClass IIOur severity:High FDA (Devices)·Z-2232-2012·Announced 2012-08-29

Terumo Interface Module Recall for Data Transfer Malfunctions

Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with reported malfunctions and smoke odors, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 232 units of the Interface Module for the CDl System 100/101. The affected modules are identified by catalog number 802558 and serial numbers 00008-00013 and 00015-00241. These modules serve as the interface between the CDl 500 monitor and the system, communicating primary pump flow data and receiving blood parameter data.

The recall was initiated after Terumo received reports of malfunctions involving the loss of data transfer capabilities. Some reports indicated that the odor of smoke was associated with these failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modules.

The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Belgium, Canada, and Germany. Users of these modules should contact Terumo Cardiovascular Systems Corporation for further instructions on how to proceed with the recall.

The recalled product

Product: Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data…
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiovascular
Hazard: malfunction
smoke-odor
Affected units: 232

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)

catalog number: 802558 and serial numbers:00008-00013
and 00015-00241.

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Terumo Cardiovascular Systems Corporation 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 4 products in this recall →

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · malfunction