Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo Cardiovascular Systems is recalling 274 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
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 is classified as FDA Class II. The hazard involves a medical device used in critical life-support procedures (cardiopulmonary bypass) where detection system failures (false alarms/over-sensitivity) pose a risk of harm, but no specific injuries or fatalities are reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 274 units of the Sarns Modular Perfusion System 8000 base, 4 pump 115V. The affected units are identified by Catalog Number 16400 and serial numbers 1001-1333. These devices are indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The recall is being conducted because the company received several reports over the last three years of malfunctions in the Air Bubble Detection System. These malfunctions manifested as over-sensitivity and false alarms, with various root causes identified. The issues occurred in systems that were either excluded from prior corrective actions or in systems where previous fixes did not resolve the problem.
The affected products were distributed worldwide, including the United States and numerous international locations. The source text does not specify the exact actions consumers or medical facilities should take, nor does it report any specific injuries or illnesses associated with these malfunctions.
The recalled product
- Product
- Sarns Modular Perfusion System 8000 base, 4 pump 115V. 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 274
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 (1)
- Catalog Number 16400 and serial number 1001-1333
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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.
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