CLASS II Device recall · Reported 23 Sep 2020 · FDA Enforcement Report
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor recalled
Terumo Cardiovascular Systems is recalling Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1//16 UAS BLK, distributed nationwide in the US. The recall was initiated on 25 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2960-2020
- FDA event ID
- 86338
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2020
- FDA classified
- 11 Sep 2020
- Reported
- 23 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 25 Aug 2020 | Recall initiated by company | |
| 11 Sep 2020 | Classified by FDA | +17 days |
| 23 Sep 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Where it was distributed
Worldwide distribution - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
Which lots are affected?
UDI: 00886799000045; Serial Numbers: 20230 20263 20265
Where was it sold?
Worldwide distribution - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 86338This product is part of a recall event; the main page for the event is Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1//32 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1//32 recalled | Terumo Cardiovascular Systems | Device Malfunction | Nationwide | |
| CLASS II | Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3//32 recalled | Terumo Cardiovascular Systems | Device Malfunction | Nationwide |
More recalls from Terumo Cardiovascular Systems
All 222| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CDI OneView System BPM Probe recalled by Terumo Cardiovascular Systems | Terumo Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Terumo CDI OneView Monitoring System Hematocrit / Oxygen recalled | Terumo Cardiovascular Systems | Device Malfunction | 6 states |
| Device | CLASS II | Cardiovascular Procedure Kits that include High Crack Check recalled | Terumo Cardiovascular Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Capiox RX15 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Capiox FX25 Hollow Fiber Oxygenator recalled | Terumo Cardiovascular Systems | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |