FDAClass IIOctober 20, 2021

smiths medical medex CBSS-5ML recall

smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094

Why was smiths medical medex CBSS-5ML 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
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Recalling firm
Smiths Medical ASD Inc.
Quantity
3620 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