MediHoney® Leptospermum Honey Tube
Brand(s)
Last updated
Summary
Product
MediHoney® Leptospermum Honey Tube
Issue
Medical devices - Sterility
Medical devices - Unauthorised device
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Industry
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| MediHoney® Leptospermum Honey Tube | All lots. | 31515 31535 |
Issue
There are potential for pinholes in the applicator pouch film which creates a sterility concern. Manufacturer reported that there have been 4 complaints reported worldwide with the potential to be related to this sterility concern as of 08/05/2024, none of which alleged serious injury or deaths. Additionally, these products were found to be unlicensed for sale in Canada and were distributed without a license.
Recall start date: September 16, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Derma Sciences, Inc.
104 Shorting Road, Toronto, Ontario, Canada, M1S 3S4
Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-76377
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