Agency classClass IIOur severity:High FDA (Devices)·Z-2348-2012·Announced 2012-09-19

Terumo Sarns Modular Perfusion System 8000 Safety Monitor Recall

Terumo is recalling eight Sarns Modular Perfusion System 8000 safety monitors due to an underrated circuit breaker that may cause the device to trip off.

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 used in cardiopulmonary bypass where a failure to stop pumps could pose a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling eight Sarns Modular Perfusion System 8000 safety monitors. These devices are indicated to warn when the blood level in the reservoir reaches the operator-set limit and to stop the arterial and cardioplegia pumps during extracorporeal circulation procedures.

The recall was initiated after Terumo's affiliate, Terumo Dubai, reported that the safety monitors were tripping off. An investigation determined that the eight affected monitors were manufactured with an underrated circuit breaker due to an inventory error. The affected units are identified by catalog number 16404 and serial numbers 4357, 4381, 4386, 4387, 4389, 4391, and 4392.

The affected monitors were distributed internationally to Terumo Dubai in the UAE. Healthcare facilities should check their inventory for these specific serial numbers and contact Terumo Cardiovascular Systems for instructions on how to proceed.

The recalled product

Product: Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified…
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiovascular
Hazard: electrical-fault
device-malfunction
Affected units: 8

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 (7)

catalog number 16404 and serial numbers: 4357
4381
4386
4387
4389
4391
and 4392.

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Terumo Cardiovascular Systems Corporation

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