Product Recall  from Integra LifeSciences

This serves as a notification of a recall on behalf of Integra LifeSciences, the manufacturer of the MediHoney® Wound & Burn Products. The voluntary recall is due to packaging failures related to the MediHoney Wound & Burn products, which could lead to a breach in the sterile barrier.

Note: If you are a distributor, promptly notify any of your customers that may have received affected product. Have the customers return any affected product to you for collection and return to Integra LifeSciences.

MediHoney® Wound & Burn Products

Packaging failures were identified related to the MediHoney Wound & Burn products, which could lead to a breach in the sterile barrier.

Status : Open

Please review the instructions below and submit your response(s) to Performance Health.

Return Instructions

1. Affected products purchased from Performance Health is limited to:
   1. Manufacturuer # 31622: MEDIHONEY HYDROGEL 2.4" X 2.4" SHEET, STERILE 1'S, 10/BOX x 5 (PK: 50/CS)
      (Performance Health Product #/SKU: 081593557)
2. If you have any opened or unopened batches of this product, follow the appropriate instructions below.

Customers (Medical Facility)

1. Complete the 'Medical Facility Acknowledgement Form' provided.
   1. If you have units of the impacted product (#31622), remove them immediately from service and quarantine them.
   2. If you have affected product, check the box "I do have affected product." and record the lot number and total quantity of the affected product that you have.
   3. If you DO NOT have affected product, check the box "I do not have affected product."
2. 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.
3. Complete the entirety of the Acknowledgement Form and send via email to FCA4@integralife.com or FAX to 1-609-750-4220
   1. Keep a copy of the form for your records.

You may download the Medical Facility Acknowledgement Form here and find page 3 for the form.

Where to find your Lot #