Drug recall
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as…
FDA recall event 83549 · Class II · ICU Medical Inc
Key facts
| Event ID | 83549 |
|---|---|
| Recall numbers | Z-0126-2020, Z-0127-2020, Z-0128-2020, Z-0129-2020, Z-0130-2020, Z-0131-2020, Z-0132-2020, Z-0133-2020, Z-0134-2020, Z-0135-2020, Z-0136-2020, Z-0137-2020 and 10 more |
| Recalling firm | ICU Medical Inc |
| Product type | Devices |
| Products | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange…, Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2…, Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant…, Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE…, Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter… and 14 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. |
| Initiation date | Jul 29, 2019 |
| Report date | Oct 23, 2019 |
| Termination date | Jan 12, 2024 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3013319212 |
At a glance
- 10–99 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: