Radiometer recalls PICO70 arterial blood samplers due to a remote risk of bacterial bloodstream infection, especially for immunosuppressed patients. The issue involves potential breaches in the sterile barrier system.
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.
Radiometer is recalling PICO70 arterial blood samplers because internal testing found breaches in the sterile barrier system. This could lead to a remote risk of bacterial infection, which might become serious or life-threatening, especially for immunosuppressed patients.
The sterile barrier system in the PICO70 samplers may have small breaches during testing. If bacteria enter the bloodstream, it could cause an infection that starts without symptoms but might progress to sepsis or septic shock.
Patients using the PICO70 arterial blood samplers for blood tests are affected. Immunocompromised individuals face a higher risk of infection.
Check for model numbers 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, or 956-547 on the sampler. These models are part of the PICO70 arterial blood sampler line.
Look for model numbers 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, or 956-547 on the sampler.
The recall describes a remote possibility of bacterial bloodstream infection, which could become serious or life-threatening, especially for immunosuppressed patients.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected models.
Immunosuppressed patients are at higher risk due to the potential for infection to progress quickly.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-1683-2021 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-1683-2021 from Radiometer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
