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[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

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Productmedex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Brand / manufacturerSmiths Medical ASD Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0092-2022
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date10 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.

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