Smiths Medical Antishunt Sets Recalled Due to Pressure and Reading Errors
Smiths Medical ASD Inc. is recalling approximately 20,800 Antishunt blood sampling sets due to reported pressure shifts and incorrect pressure readings. The affected model was 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: This is an FDA Class II medical device recall. No illnesses or injuries are reported in the source material. However, pressure shifts and incorrect pressure readings in a blood sampling system present a risk of harm, qualifying this as a High severity recall per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Smiths Medical ASD Inc. is recalling approximately 20,800 units of its Antishunt blood sampling sets (Model Number DPSHC0091) due to reported pressure shifts and incorrect pressure readings.
The recalled product is the CBSS-5ML Antishunt set measuring 172/15cm with all production codes affected. The sets were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Pressure shifts and incorrect pressure readings in the closed blood sampling system could affect the accuracy and proper operation of blood sampling procedures. Smiths Medical ASD Inc. initiated this recall to address the reported issues with these devices.
The recalled product
- Product
- smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- pressure-shift
- incorrect-pressure-reading
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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