Health product recall

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