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
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
A. CLINITUBES with Capillary Caps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
100161
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK
B. Safe CLINITUBES Blood Sampler
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
400622
Companies
- Manufacturer
-
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK