Smiths Medical LogiCal Blood Sampling Sets Recalled for Pressure Reading Errors
Smiths Medical ASD Inc. is recalling 870 units of LogiCal blood sampling sets distributed across Europe and Saudi Arabia due to reported pressure shifts and incorrect pressure readings.
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: This Class II medical device recall involves reported malfunctions (pressure shifts and incorrect readings) that could compromise patient sample collection accuracy. No illnesses or injuries have been reported, consistent with the 'risk-of-harm' category where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling 870 units of its LogiCal closed blood sampling system sets, Model DPSHC0082. These sets are used for collecting blood samples in clinical settings.
The recalled sets are reported to exhibit pressure shifts and incorrect pressure readings during use. These malfunctions could affect the proper collection and quality of blood samples.
The affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia. All production codes of this model are included in the recall.
The recalled product
- Product
- smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Blood Sampling
- Affected units
- 870
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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