Terumo Advanced Perfusion System 1 Ultrasonic Air recall
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand…
Why was Terumo Advanced Perfusion System 1 Ultrasonic Air 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 100
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- September 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)