[Recalled] medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1 — Reported pressure shifts and incorrect pressure readings in LogiCal Closed Bloo… | FDA 20
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1 |
|---|---|
| Brand / manufacturer | Smiths Medical ASD Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0092-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 March 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Smiths Medical ASD Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.