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MediHoney recallZ-0054-2025 · Integra LifeSciences Corp. · initiated Sep 13, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for pinholes in the applicator pouch film which creates a sterility concern.

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-0054-2025
Status
Open, Classified
Initiated by the company
Sep 13, 2024
Posted by the FDA
Oct 10, 2024
Recalling firm
Integra LifeSciences Corp.
Quantity
120124 units
Product code
FRO
FDA submissions
K080315
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 description

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)

Code information (models, lots, serial numbers)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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