FDA Device recall Z-0949-2022
Cardiovascular Procedure Kit catalog # 76645 & 73806
- FDA Device
- Class II
- terminated
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Cardiovascular Procedure Kit catalog # 76645 & 73806 by Terumo Cardiovascular Systems, citing potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0949-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-03 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
Cardiovascular Procedure Kit catalog # 76645 & 73806
Reason
Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.
Identifiers
| code_info | [Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398,…[Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398] |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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-0949-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.