Blood sampling system sets recalled for pressure reading and measurement errors
Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device recall with no reported illnesses or injuries. The hazard is a functional defect affecting pressure accuracy in a blood sampling device, which is a risk-of-harm medical device. Per the rubric, recalls involving risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Smiths Medical ASD Inc. is recalling 150 units of its medex CBSS-5ML blood sampling system sets (Model Number DPSHC0092) distributed internationally.
The devices have been reported to exhibit pressure shifts and provide incorrect pressure readings during blood sampling procedures. These functional issues may affect the accuracy and reliability of the blood collection process.
The affected sets were distributed to medical facilities in Austria, France, Germany, Great Britain, and Saudi Arabia. All product codes are included in this recall.
The recalled product
- Product
- smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Blood Sampling
- Affected units
- 150
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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