CLINITUBES with Capillary Caps & Safe CLINITUBES Blood Sampler (2020-03-03)

Starting date:

March 3, 2020

Posting date:

June 12, 2020

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-73303

Last updated: 2020-06-12

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  Reason
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  Affected products

Affected Products

A. CLINITUBES with Capillary Caps

B. Safe CLINITUBES Blood Sampler

Reason

Radiometer Medical ApS has received an increased number of complaints stating that several customers have had troubles when using SafeClinitubes (942-892). The SafeClinitubes have little or no aspiration, which means that it is difficult or impossible to collect the patient blood with the SafeClinitubes. The lack of aspiration may lead to the hazardous situation of delayed availability of fetal scalp pH measurement results during the delivery process.

Affected products