Drug recall
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d)…
FDA recall event 88667 · Class II · Smiths Medical ASD Inc.
Key facts
| Event ID | 88667 |
|---|---|
| Recall numbers | Z-0092-2022, Z-0093-2022, Z-0094-2022, Z-0095-2022, Z-0096-2022, Z-0097-2022, Z-0098-2022, Z-0099-2022, Z-0100-2022, Z-0101-2022, Z-0102-2022, Z-0103-2022 |
| Recalling firm | Smiths Medical ASD Inc. |
| Product type | Devices |
| Products | medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1, smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076, smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081, smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091, smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 and 7 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets. |
| Initiation date | Mar 10, 2020 |
| Report date | Oct 20, 2021 |
| Termination date | Sep 22, 2023 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3012307300 |
At a glance
- 10–99 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: