Z-2960-2020Class II

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 -

Name: Z-2960-2020 Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 -
Creator: Terumo Cardiovascular Systems Corporation
Published: 2020-08-25
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2020-08-25 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 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... on 2020-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2960-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-25
Posted: 2020-09-12
Terminated: 2021-01-29
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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.
Root cause tag: manufacturing process
FDA root cause: 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: 3
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: UDI: 00886799000045; Serial Numbers: 20230 20263 20265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2960-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2959-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11
Z-2960-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11
Z-2961-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11

Product code DTQ

K172220Class IIAdvanced Perfusion System 1Terumo Cardiovascular Systems Corporation / cleared 2017-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)