Recall Z-0054-2025

Reason for recall

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

FDA-determined 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