Pediaprep & Lemonprep Tubes, and Pediaprep & Lemonprep Single Use Cups (2019-10-06)
- Starting date:
- October 6, 2019
- Posting date:
- January 6, 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-72001
Last updated: 2020-01-28
Affected Products
A. Pediaprep Tubes
B. Pediaprep Single Use Cups
C. Lemonprep Tubes
D. Lemonprep Single Use Cups
Reason
Mavidon is recalling all lots of Pediaprep Tubes and Pediaprep Single Use Cups, Lemonprep Tubes and Lemonprep Single Use Cups due to potential contamination with burkholderia cepacia (b. Cepacia), a multi-drug resistant pathogenic microorganism.
Affected products
A. Pediaprep Tubes
Lot or serial number
All lots.
Model or catalog number
MD0033-T
Companies
- Manufacturer
-
Mavidon Medical
6625 White Dr.
Riviera Beach
33407
Florida
UNITED STATES
B. Pediaprep Single Use Cups
Lot or serial number
All lots.
Model or catalog number
MD0033-SUP
Companies
- Manufacturer
-
Mavidon Medical
6625 White Dr.
Riviera Beach
33407
Florida
UNITED STATES
C. Lemonprep Tubes
Lot or serial number
All lots.
Model or catalog number
MD0019T
Companies
- Manufacturer
-
Mavidon Medical
6625 White Dr.
Riviera Beach
33407
Florida
UNITED STATES
D. Lemonprep Single Use Cups
Lot or serial number
All lots.
Model or catalog number
MD0019-SUP
Companies
- Manufacturer
-
Mavidon Medical
6625 White Dr.
Riviera Beach
33407
Florida
UNITED STATES