Smiths Medical closed blood sampling system sets recalled for pressure reading errors
Smiths Medical is recalling CBSS-5ML blood sampling system sets due to reported pressure shifts and incorrect pressure readings that may affect the accuracy of blood sample collection.
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 recall of a medical device with reported pressure shifts and incorrect readings that could compromise sample integrity and patient safety. No adverse events are documented in the source material, placing this at score 3 per the rubric: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Medex CBSS-5ML Zweifach closed blood sampling system sets, Model Number DPSHC0090. The devices have been reported to experience pressure shifts and incorrect pressure readings.
These issues may compromise the accuracy and integrity of blood samples collected using the affected devices. The affected units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Healthcare facilities and clinicians using these devices should discontinue use immediately and contact Smiths Medical ASD Inc. for instructions regarding replacement or return of the affected units.
The recalled product
- Product
- smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 20
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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