Recall MonitorHealth Products
Medihoney® Wound and Burn Products
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery, Health products - Medical devices - General hospital and personal use
Product: Medihoney® Wound and Burn Products
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Medihoney® Derma Cream | More than 10 numbers, contact manufacturer. | 597 |
| MediHoney® Leptospermum Honey Tube | More than 10 numbers, contact manufacturer. | 405 |
| Medihoney® With Active Leptospermum Honey | More than 10 numbers, contact manufacturer. | 795 |
| Medihoney® With Active Leptospermum Honey | More than 10 numbers, contact manufacturer. | 794 |
| Medihoney® With Active Leptospermum Honey | More than 10 numbers, contact manufacturer. | 796 |
| Medihoney® With Active Leptospermum Honey | More than 10 numbers, contact manufacturer. | 793 |
| Medihoney® Barrier Cream | More than 10 numbers, contact manufacturer. | 800 |
| Medihoney® Barrier Cream | More than 10 numbers, contact manufacturer. | 582 |
Issue
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.