Drug recall
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
FDA recall event 77717 · Class II · Sorin Group USA, Inc.
Key facts
| Event ID | 77717 |
|---|---|
| Recall numbers | Z-2771-2017, Z-2772-2017, Z-2773-2017, Z-2774-2017, Z-2775-2017, Z-2776-2017 |
| Recalling firm | Sorin Group USA, Inc. |
| Product type | Devices |
| Products | STOCKERT Heater-Cooler System 3T, 120V/60 Hz, STOCKERT Heater-Cooler System 3T, 127V/60 Hz, STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz, STOCKERT Heater-Cooler System 3T, 208V/60 Hz, STOCKERT Heater-Cooler System 3T, 230 V and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. |
| Initiation date | Jun 30, 2017 |
| Report date | Aug 2, 2017 |
| Termination date | Oct 10, 2023 |
| City | Arvada |
| State | CO |
| Country | United States |
| FEI number | 1718850 |
At a glance
- 1–9 Products in this recall
- 1–9 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: