Smiths Medical blood sampling system recalled for pressure reading errors
Smiths Medical has recalled its Medex closed blood sampling system due to pressure shifts and incorrect pressure readings. Approximately 13,620 units were distributed internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with a theoretical risk of patient harm (incorrect blood pressure readings affecting clinical decisions), but no injuries or illnesses have been reported. Per the rubric, this qualifies as High severity (3) for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. has recalled the Medex CBSS-5ML Single Set (Model Number DPSHC0093), a closed blood sampling system device. The recall affects approximately 13,620 units distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
The affected devices may experience pressure shifts and incorrect pressure readings during clinical use. These malfunctions could impact the accuracy of blood pressure measurements and affect clinical decision-making.
Healthcare facilities and clinical settings in the affected regions that have received this device should contact Smiths Medical ASD Inc. for replacement or return instructions. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 13,620
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.
Part of a larger recall action
This product is one of 12 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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