The Recall Desk
HighFDA (Devices)·Z-0092-2022·Announced 2021-10-20

Medex LogiCal Closed Blood Sampling System Recalled for Pressure Reading Errors

Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of a medical device. No illnesses or injuries have been reported. The hazard—incorrect pressure readings in a blood sampling system—poses a risk of harm to patient care, but without reported incidents, the severity is classified as High per the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smiths Medical ASD Inc. is recalling the medex LogiCal 5mL Closed Blood Sampling System across multiple model numbers. The affected models include MX961E181P1, MX961E211P1, MX962E211P1, MX96AE181P1, and MX96AE211P1. Approximately 17,980 units have been distributed.

The recall was initiated due to reported pressure shifts and incorrect pressure readings in the system. These errors could impact the accuracy of blood sampling and potentially affect patient care decisions based on the readings.

The affected systems were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia. Healthcare facilities and providers using these systems should contact Smiths Medical ASD Inc. for recall instructions and replacements.

The recalled product

Product
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Blood Sampling
Hazard
Affected units
17,980

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All codes

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 12 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · incorrect pressure reading

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