LemonPrep Tubes and Single Cups (2019-09-06)

Starting date:

September 6, 2019

Posting date:

October 11, 2019

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-71277

Last updated: 2019-12-20

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  Reason
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  Affected products

Affected Products

A. LemonPrep Tubes

B. LemonPrep Single Use Cups

Reason

Mavidon is recalling certain lots distributed from September 2017 to January 2019 of LemonPrep and LemonPrep single use cups due to its potential to be contaminated with burkholderia cepacia. Contaminated products with burkholderia cepacia can potentially result in serious infections, may be life-threatening in patients with compromised immune systems. To date, Mavidon ahs received one report of adverse even related to this recall outside of Canada.

Affected products