MediHoney recallZ-1168-2025 · Integra LifeSciences Corp. · initiated Jan 10, 2025

Why it was recalled

Potential that the induction seal is not completely sealed to the device tube packaging.

FDA root cause category: Process control

What the company is doing

On January 10, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken by Customers (Medical Facility): 1. If you do not have affected product, check the box, I do not have affected product. 2. If you do have units of the affected product (Table 1), remove them immediately from service and quarantine them. 3. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the total quantity of the affected product that you have. 4. 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. 5. Complete and return the Medical Facility Acknowledgement Form to [email protected] or FAX to 1-609- 750-4220. 6. Keep a copy of the form for your records. 7. When the form from you is received, and it is noted that you have affected product, Customer Service will contact you and provide an RMA number and directions to return the product. You can request a credit for the quantities returned. Actions to be Taken by Distributors: 1. If you do not have affected product, check the box, I do not have affected product. 2. If you do have the affected product (Table 1), remove the product from further distribution. 3. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have. 4. Please check your customer traceability records for shipments of above catalog and lot numbers. 5. Forward this notice to any of your customers that have purchased the affected product (Table 1). 6. Complete and return the Distributor Acknowledgement Form to [email protected] or FAX to 1-609-750- 4220. 7. Keep a copy of the form for your records. 8. When the form from you and/or your customer is received, and it is noted that you and/or your customer has affected product, Customer Service will contact you and/or your customer and provide an RMA n

Recall details

Recall number

Z-1168-2025

Status

Open, Classified

Initiated by the company

Jan 10, 2025

Posted by the FDA

Feb 12, 2025

Recalling firm

Integra LifeSciences Corp.

Quantity

12,166 units

Product code

FRO

FDA submissions

K101793

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.

Product description

Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used. Component: No

Devices named in this recall

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

• MediHoney® 31815

  Acell, Inc. · Dressing, wound, drug
  2 recalls7 reports

Product lines

• MediHoneyAcell, Inc. · 16 models · 19 reports · 12 recalls