Smiths Medical Blood Sampling System Recalled for Pressure Malfunction and Incorrect Readings
Smiths Medical LogiCal MEDEX closed blood sampling system sets are recalled due to reported pressure shifts and incorrect pressure readings. Approximately 3,620 units were distributed to 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: Class II FDA recall for a medical device with reported functional defects affecting blood sampling. Classified as a risk-of-harm product where no injuries or illnesses have been reported in the source material.
Plain-English summary
Smiths Medical ASD Inc. is recalling 3,620 units of the MEDEX CBSS-5ML double set (model DPSHC0094), a closed blood sampling system. The product was distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
The recalled systems have been reported to have pressure shifts and incorrect pressure readings, which could affect the proper functioning of the blood sampling system during clinical use.
This recall affects healthcare facilities, hospitals, and medical professionals in the countries where the product was distributed.
The recalled product
- Product
- smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- pressure-malfunction
- incorrect-readings
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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