Radiometer Recalls PICO70 Arterial Blood Samplers Due to Sterile Barrier Breach

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 PICO7

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.

Distribution

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