Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors
Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
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 a Class II medical device recall for reported pressure shifts and incorrect pressure readings in a critical blood sampling system. Although no illnesses or injuries are reported in the source, measurement errors in equipment used for blood collection represent a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Smiths Medical ASD Inc. is recalling LogiCal Closed Blood Sampling System (CBSS) 5 ml sets, Model Number DPSHC0083. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
The recalled sets may exhibit pressure shifts and incorrect pressure readings. These measurement errors could affect the reliability of blood sampling procedures that depend on accurate pressure monitoring.
Users of these products are advised to immediately check their inventory for affected units and contact Smiths Medical ASD Inc. for return instructions and replacement options.
The recalled product
- Product
- smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 7,080
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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