Radiometer Arterial Blood Sampler recalled due to sterility guarantee loss
Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.
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: FDA Class II recall for loss of sterility assurance in blood-collection devices. Without reported illnesses or injuries, the severity reflects the serious potential risk of contamination rather than actualized harm.
Plain-English summary
Radiometer Medical ApS is recalling Arterial Blood Samplers (REF:956-552, PIC050), 1 X 2 mL with 80 IU electrolyte-balanced heparin. The manufacturer identified that sterility cannot be guaranteed throughout the shelf life of these devices, triggering an FDA Class II recall.
The recall involves 7,228 boxes (100 units per box) distributed worldwide, including to healthcare facilities in 37 US states, Washington DC, and 32 additional countries spanning North America, Europe, Africa, Asia, South America, and the Middle East.
Loss of sterility assurance in blood-collection devices creates a risk of contamination. Healthcare providers with the recalled devices should contact Radiometer Medical ApS for guidance on appropriate handling and next steps.
The recalled product
- Product
- Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
- Manufacturer
- Radiometer Medical ApS
- Hazard
- sterility-loss
- contamination-risk
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 Lots" UDI/DI: 05700699565525
Distribution
Distributed nationwide across the United States.
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