Reported Jun 2, 2021 · Terminated
PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler…
Radiometer Medical ApS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer Medical ApS · Akandevej 21 · Bronshoj, N/A · N/A
Is this the product you have?
- PIC070 Arterial
- Blood Sampler PICO70 - Product UsagePreheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis
- Model Number/Product Description
956-518 PICO70 w/o needle956-519 PICO70 w/o needle956-522 PICO70 22G x 25 mm956-525 PICO70 22G x 32 mm956-529 PICO70 23G x 16 mm956-533 PICO70 23G x 25 mm956-534 PICO70 23G x 32 mm956-547 PICO70 25G x 16 mm
- Lot codes and dates
- Model NumbersPICO70
- Arterial blood sampler without needle
956-518956-519PICO70
- Arterial blood sampler with needle
956-522956-525956-529956-533956-534956-547
- Amount recalled
- 348,178 boxes worldwide (1,883 boxes in the U.S.)
Where it was sold
Why it was recalled
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.
This product could cause temporary or reversible health problems — stop using it.
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