Drug recall
Pressure Monitoring Set, C-PMS, G02838
FDA recall event 85605 · Class II · Cook Inc.
Key facts
| Event ID | 85605 |
|---|---|
| Recall numbers | Z-2203-2020, Z-2204-2020 |
| Recalling firm | Cook Inc. |
| Product type | Devices |
| Products | Pressure Monitoring Set, C-PMS, G02838, Pressure Monitoring Tray, C-PMSY, G02854 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion. |
| Initiation date | Apr 30, 2020 |
| Report date | Jun 10, 2020 |
| Termination date | Mar 29, 2021 |
| City | Bloomington |
| State | IN |
| Country | United States |
| FEI number | 1820334 |
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: