Drug recall
Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog…
FDA recall event 78546 · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Event ID | 78546 |
|---|---|
| Recall numbers | Z-0256-2018, Z-0257-2018 |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Product type | Devices |
| Products | Custom surgical kits containing TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 and (b) LH130J Catalog numbers: US distribution: LH130 74369 71156 71551-02 71413 71692 74102 75490 74432-01 75477…, TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve. |
| Initiation date | Jun 27, 2017 |
| Report date | Dec 27, 2017 |
| Termination date | Jul 16, 2019 |
| City | Elkton |
| State | MD |
| Country | United States |
| FEI number | 3000204839 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: