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)
This recall is currently active, issued October 10, 2024. It was issued by Integra Lifesciences Corp..
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- September 13, 2024
- Posted
- October 10, 2024
- Recall Number
- Z-0054-2025
- Quantity
- 120124 units
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
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.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
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 FCA2@integralife.com 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 FCA2@integralife.com 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: custsvcnj@integralife.com