Agency classClass IIOur severity:High FDA (Devices)·Z-1683-2021·Announced 2021-06-02

Radiometer Recalls PICO70 Arterial Blood Samplers Due to Sterile Barrier Breach

Radiometer is recalling PICO70 Arterial Blood Samplers because a sterile barrier breach was found during testing, posing a risk of bacterial infection.

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: The recall involves a risk-of-harm product (sterile barrier breach leading to potential sepsis) where no injuries or illnesses have been reported yet, fitting the 'High' severity criteria.

Plain-English summary

Radiometer Medical ApS is recalling the PICO70 Arterial Blood Sampler product line. The recall is due to a breach in the sterile barrier system observed during internal stress testing on one sample. The affected products are preheparinized, electrolyte-balanced samplers used for collecting arterial blood samples for pH, blood gas, oximetry, electrolyte, and metabolite analysis.

The sterile barrier breach creates a remote possibility of bacterial bloodstream infection. While such infections may be asymptomatic, they can progress to sepsis or life-threatening septic shock. Immunosuppressed patients are noted to be at particular risk. The recall covers 348,178 boxes worldwide, including 1,883 boxes in the United States, with distribution across numerous states and countries.

Healthcare providers and consumers should stop using the affected PICO70 Arterial Blood Samplers and contact Radiometer Medical ApS for instructions on return or replacement.

The recalled product

Product: PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, 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…
Manufacturer: Radiometer Medical ApS
Category: Medical Device — Blood Collection Devices
Hazard: infection
sepsis
sterile-barrier-breach

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 (10)

Model Numbers: PICO70
Arterial blood sampler without needle: 956-518
956-519
PICO70
Arterial blood sampler with needle: 956-522
956-525
956-529
956-533
956-534
956-547

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Same manufacturer · Radiometer Medical ApS

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