Smiths Medical blood sampling system recalled for pressure measurement errors
Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.
What this means for you
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: FDA Class II recall of a blood sampling device with reported measurement failures (pressure shifts and incorrect pressure readings) that pose a potential safety risk. No illnesses, injuries, or adverse outcomes have been reported, which per the rubric keeps this at the High level rather than Severe.
Plain-English summary
Smiths Medical ASD Inc. is recalling approximately 3,100 units of the MEDEX CBSS 2-fach Druckmesset mit Option blood sampling system (Model Number DPSHC0076) distributed to multiple countries.
The recalled devices may experience pressure shifts and display incorrect pressure readings during use. These measurement failures could compromise the accuracy of blood collection procedures.
The affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia. The recall applies to all codes of this model.
Healthcare facilities and users of these devices should contact Smiths Medical ASD Inc. for instructions on replacement or device management.
The recalled product
- Product
- smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 3,100
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.
See all 12 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · pressure shift
See all →- HighSmiths Medical LogiCal Blood Sampling Sets Recalled for Pressure Reading Errors
FDA (Devices) · 2021-10-20
- HighSmiths Medical Antishunt Sets Recalled Due to Pressure and Reading Errors
FDA (Devices) · 2021-10-20
- HighSmiths Medical closed blood sampling system sets recalled for pressure reading errors
FDA (Devices) · 2021-10-20
- HighMedex LogiCal Closed Blood Sampling System Recalled for Pressure Reading Errors
FDA (Devices) · 2021-10-20
- HighBlood sampling system sets recalled for pressure reading and measurement errors
FDA (Devices) · 2021-10-20