FDA Device recall Z-0966-2019
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
- FDA Device
- Class II
- terminated
- Published 2019-03-06
On 2019-03-06 the FDA classified a Class II recall of Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 by Terumo Cardiovascular Systems, citing presence of natural rubber latex is not declared in the label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0966-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-20 |
| Published | 2019-03-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | TX |
Product
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Reason
Presence of natural rubber latex is not declared in the label
Identifiers
| code_info | Lot Numbers: V A30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Terumo Cardiovascular Systems
- CDI OneView System BPM Probe: Cat
FDA Device · Class II · 2025-07-02 · Terumo Cardiovascular Systems - Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Device · Class II · 2025-04-09 · Terumo Cardiovascular Systems - Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Part Number: 6375 16010 62974 65246 66312 66342 66388 66650 66…
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-0966-2019%22
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