Drug recall
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO…
FDA recall event 82489 · Class II · Stryker Corporation
Key facts
| Event ID | 82489 |
|---|---|
| Recall numbers | Z-1726-2019, Z-1727-2019, Z-1728-2019 |
| Recalling firm | Stryker Corporation |
| Product type | Devices |
| Products | Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile., Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile., Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The heated tube sets were consistently leaking and detaching from the cassette. |
| Initiation date | Mar 7, 2019 |
| Report date | Jun 12, 2019 |
| Termination date | Mar 8, 2024 |
| City | San Jose |
| State | CA |
| Country | United States |
| FEI number | 2936485 |
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: