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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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  Class 2 Device Recall Terumo Advanced Perfusion System 1 see related information
Date Initiated by Firm August 25, 2020
Create Date September 12, 2020
Recall Status1 Terminated 3 on January 29, 2021
Recall Number Z-2959-2020
Recall Event ID 86338
510(K)Number K172220  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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 air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Code Information 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 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Action Urgent Medical Device Removal notification letters dated 8/25/20 were sent to customers. Terumo CVS is removing the affected ABD sensors from the field. A Terumo Associate will contact all affected customers to coordinate the shipment of a replacement device and subsequent return of the affected unit. The replacement ABD sensor supplied by Terumo CVS will be part of a kit containing a cable and a bracket which are not affected by this removal. The cable and the bracket do not require replacement. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Correction and assure that all users have received notice of this issue. 2. Confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. 3. Review Product Return instructions when provided by separate email communication. Tracking information on replacement device will be provided as well as a Return Goods Authorization (RGA) number to facilitate the return of the affected device., 4. Once the replacement shipment has been received, remove the affected ABD sensor and replace it with the new ABD sensor provided by Terumo CVS. 5. Return affected ABD sensor using the packing container and shipping materials received with the replacement ABD device. Please mark the RGA number on the outside of the box. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: ¿ Terumo CVS Customer Service: 1.800.521.2818 Monday  Friday, 8 a.m.  6 p.m. ET ¿ Recall Fax: 1.734.741.6149 Review this Medical Device Correction and assure that all users have received notice of this issue. A Terumo Associate will contact all affected customers to coordinate the shipment of a replacement ABD sensor and subsequent return of the affected unit. Terumo CVS recommends that you continue using your ABD sensor while waiting for a replacement. If you experience an ABD sensor failure, or have questions, contact Terumo CVS Customer Service: 800.521
Quantity in Commerce 100
Distribution Worldwide distribution - US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = Terumo Cardiovascular Systems Corporation
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