FDA Device recall Z-1458-2017
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound en…
- FDA Device
- Class II
- terminated
- Published 2017-03-22
On 2017-03-22 the FDA classified a Class II recall of Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound en… by Terumo Cardiovascular Systems, citing terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1458-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-20 |
| Published | 2017-03-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir.
Reason
Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
Identifiers
| code_info | Level Sensor II Pads, Catalog No. 195240, UDI No: 10886799001704, Lot Numers Ranging from 782300 through 817488, Manufa…Level Sensor II Pads, Catalog No. 195240, UDI No: 10886799001704, Lot Numers Ranging from 782300 through 817488, Manufactured from 20-Nov2015 to 25-Nov-2016; Distributed from 23-Nov-2015 through 15-Dec-2016. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems - CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
FDA Device · Class II · 2023-04-12 · Terumo Cardiovascular Systems
All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1458-2017%22
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