MediHoney Wound & Burn Dressing Paste
Voluntary Medical Device Correction
MediHoney Wound & Burn Dressing Paste
This notification is to inform you of a product correction directed to us from McKesson Medical-Surgical Inc. regarding an Urgent Device Correction affecting all lots of Integra MediHoney Wound & Burn Dressing paste, with the expiration dates below:
| MMS # | MFG Catalog # | Description | Affected Lot(s) | Expiration Date |
|---|---|---|---|---|
| 710610 | 31535 | DRESSING, MEDIHONEY 3.5OZ TU (12/CS) | All Lots distributed from 12/17/2020 to 07/22/2024 | 08/01/2024 to 06/01/2028 |
| 699433 | 31515 | DRESSING, MEDI-HONEY 1.5OZ (12TU/CS) | All Lots distributed from 12/17/2020 to 07/22/2024 | 08/01/2024 to 06/01/2028 |
This notice has been issued due to the potential for pinholes in the applicator pouch film which creates a sterility concern. The paste is not impacted by this sterility concern. There is no risk to the end user if the applicator is not used to apply the paste directly on the wound. Affected product first shipped December 17, 2020.
Immediately examine your supply to determine if the items above fall within the distribution date ranges. If you do have units of the impacted product (table above), remove the applicator immediately from service and discard it.
resources
Consumers who have these products may also contact Integra via e-mail at custsvcnj@integralife.com, or contact their Customer Service Monday to Friday 8:00AM to 8:00 PM EST at 1-800-654-2873.