FDA-Device2021-10-20Class II

smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

Smiths Medical ASD Inc.
Hazard

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

Sold states
Austria, France, Germany, Great Britain, and Saudi Arabia
Affected count
20800 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2022

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