FDAClass IIOctober 20, 2021

medex LogiCal recall

medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1

Why was medex LogiCal recalled?

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All codes

Product
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Recalling firm
Smiths Medical ASD Inc.
Quantity
17980 units
Distribution
Austria, France, Germany, Great Britain, and Saudi Arabia
Recall date
October 20, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls