FDA Device recall Z-2550-2018
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary b…
- FDA Device
- Class II
- terminated
- Published 2018-08-01
On 2018-08-01 the FDA classified a Class II recall of Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary b… by Terumo Cardiovascular Systems, citing kit was labeled with the incorrect Expiration Date of April 30, 2019.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2550-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-12 |
| Published | 2018-08-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | FL |
Product
Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.
Reason
Kit was labeled with the incorrect Expiration Date of April 30, 2019.
Identifiers
| code_info | Lot Number: VE17 |
|---|
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 · 2024-04-10 · Terumo Cardiovascular Systems - CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
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-2550-2018%22
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