Recall Z-0103-2022— Smiths Medical ASD Inc.

Name: FDA recall Z-0103-2022
Creator: U.S. Food and Drug Administration
Published: 2020-03-10

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-03-10, terminated 2023-09-22. FDA's recall record names no specific 510(k) clearance for this event. Product: smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094. Reason: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-03-10
Terminated: 2023-09-22
Firm location: Minneapolis, MN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.