Blood Sampling System Recalled for Pressure Shifts and Incorrect Readings
Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings. Approximately 10,620 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
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 involving reported pressure shifts and incorrect pressure readings in a medical device used for blood sampling. These measurement errors represent a risk of harm to the accuracy and reliability of patient sampling procedures.
Plain-English summary
Smiths Medical ASD Inc. is recalling the LogiCal Closed Blood Sampling System sets, Model Number DPSHC0081 (5 ml with 60 cm proximaler Entnahmeport). The recall affects approximately 10,620 units distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
The recalled systems exhibit pressure shifts and incorrect pressure readings. These measurement errors could affect the functionality and reliability of the blood sampling system and the accuracy of patient samples.
Healthcare providers who have received these units should cease use and contact Smiths Medical ASD Inc. for instructions on return or replacement. Any instances of pressure shifts or incorrect readings should be reported to the FDA and the manufacturer.
The recalled product
- Product
- smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- pressure-shift
- incorrect-pressure-reading
- measurement-error
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.
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