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.
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation is recalling 100 units of the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor (Catalog Number 5773) distributed worldwide and throughout the United States. Internal testing at the supplier discovered that a crimped wire was installed backwards in the air bubble detector sensor connector, which prevents the wire from properly locking into the mating connector.
The defect creates an intermittent connection that may result in false air bubble alarms. The recalled devices are identified by UDI 00886799000038 and include serial numbers 20288 through 20579 (with some numbers in that range excluded). The recall record does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution - US Nationwide distribution. Quantity: 100 Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.