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
- incorrect-pressure-reading
- pressure-shift
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.
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