Smiths Medical HemoDraw Plus Blood Sampling Sets Recalled for Pressure Monitoring Errors
Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to 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 involving a risk-of-harm product. The device malfunction—pressure shifts and incorrect pressure readings in the monitoring system—could affect the safety of blood sampling procedures. While no adverse events or injuries have been reported, the functional defect in a safety-critical monitoring component warrants a High severity classification.
Plain-English summary
Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System (Model Numbers: MX961H182P1, MX961H212P1, MX962H182P1, MX962H212P1). The recall addresses reported pressure shifts and incorrect pressure readings in the LogiCal Pressure Monitoring System component.
The pressure monitoring system in these blood sampling sets is not functioning as designed, with shifts in pressure measurement and inaccurate readings reported during use.
The affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia. All production codes are included in this Class II medical device recall issued by the FDA and conducted by the manufacturer.
The recalled product
- Product
- smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 140
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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