CLASS II Device recall · Reported 23 Sep 2020 · FDA Enforcement Report
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3//32 recalled
Terumo Cardiovascular Systems is recalling Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3//32, 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-2959-2020
- 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 3/8x3/32, Catalog Number 5773 - 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: 00886799000038; Serial Numbers: 20288 20289 20290 20291 20292 20293 20294 20295 20296 20299 20300 20301 20302 20306 20307 20308 20309 20310 20312 20317 20318 20320 20321 20322 20323 20324 20326 20328 20329 20331 20332 20334 20338 20339 20341 20342 20343 20344 20345 20346 20347 20348 20349 20350 20351 20352 20358 20365 20368 20373 20374 20375 20381 20382 20383 20384 20385 20387 20388 20392 20393 20395 20396 20397 20398 20399 20401 20402 20403 20404 20405 20408 20410 20411 20412 20555 20556 20557 20558 20559 20560 20561 20562 20563 20564 20565 20566 20567 20568 20569 20570 20571 20572 20573 20574 20575 20576 20577 20578 20579
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 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
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |