PICO70 Arterial Blood Sampler (2021-03-24)

Starting date:

March 24, 2021

Posting date:

April 14, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75381

Last updated:
2021-04-14

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  Reason
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  Affected products

Affected Products 

PICO70 Arterial Blood Sampler

Reason

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.

Affected products