Medihoney® wound and burn products (Medihoney® Derma Cream — catalogue 597; MediHoney® Leptospermum Honey Tube — 405; Medihoney® With Active Leptospermum Honey — 795, 794, 796, 793; Medihoney® Barrier Cream — 800, 582) are affected. Sterile products have identified packaging failures that could breach the sterile barrier, and non-sterile products have manufacturing and packaging control issues that could result in inadequate packaging. Contact the manufacturer for additional information.
What's being recalled
Companies: Derma Sciences, Inc., 104 Shorting Road, Toronto, Ontario, Canada, M1S 3S4.
How to identify it
Affected products: Medihoney® Derma Cream; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 597
Affected products: MediHoney® Leptospermum Honey Tube; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 405
Affected products: Medihoney® With Active Leptospermum Honey; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 795
Affected products: Medihoney® With Active Leptospermum Honey; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 794
Affected products: Medihoney® With Active Leptospermum Honey; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 796
Affected products: Medihoney® With Active Leptospermum Honey; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 793
Affected products: Medihoney® Barrier Cream; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 800
Affected products: Medihoney® Barrier Cream; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 582
The hazard
Sterile products:
During an investigation, packaging failures were identified related to the Medihoney® wound & burn products, which could lead to a breach in the sterile barrier.
Non-sterile products:
During an investigation, Integra Lifesciences identified inadequately controlled good manufacturing processes related to the production of Medihoney® products which could result in inadequate packaging.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)