510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0054-2025Class II

MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model...

Integra LifeSciences Corporation / initiated 2024-09-13 / Open, Classified / root cause: packaging
FDA source (opens on fda.gov)

Integra LifeSciences Corp. began a recall of MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) on . FDA classified it as Class II and gives the reason as "There is a potential for pinholes in the applicator pouch film which creates a sterility concern". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0054-2025
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Integra LifeSciences Corporation
Product
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
Product code
FRO Dressing, Wound, Drug
Reason for recall
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Root cause tag
packaging
FDA root cause
Under Investigation by firm
Action
An URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION letter dated 9/13/24 was sent to customers. Actions to be Taken by Customers (Medical Facility): 1. Complete the Medical Facility Acknowledgement Form below. 2. If you do have units of the impacted product (Table 1) remove the applicator immediately from service and discard it. 3. Forward this notice to those who utilize the product so they are aware of this recall and can identify any affected product that may remain in clinical areas. 4. Return the Medical Facility Acknowledgement Form to [email protected] or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. OR Actions to be Taken by Distributors: 1. Complete the Distributor Acknowledgement Form below. 2. Please print and include a copy of this notice with every shipment of impacted products (Table 1) that have not yet been shipped to customers. 3. Return the Acknowledgement Form to [email protected] or FAX to 1-609-750-4220. 4. Keep a copy of the form for your records. 5. Forward a copy of this notice to any customers that have purchased the impacted products (Table 1). Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected]
Quantity in commerce
120124 units
Distribution
Worldwide - US Nationwide distribution in the states of MN, IL, UT, FL, NC, CA, MO, IN, MS, OH, PA, TX, HI, MA, WA, GA, AZ, VA, NY, CO, MI, OK, NV, NJ, SC, OR, VT, DC, WI, TN, WV, KS, AL, NE, MD, ID, LA, AR, KY, IA, AK, NM, ME, RI and the countries of Madagascar, Malaysia, Guam.
Product codes and lots
Model 31515 UDI-DI: 10381780486824; Model 31535 UDI-DI: 10381780486831; All lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0054-2025
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0054-2025Class IIOngoingVoluntary: Firm initiated