Class 2 Device Recall Manuka Honey Wound Gel

• Date Initiated by Firm: March 06, 2018
• Create Date: May 04, 2018
• Recall Status: Terminated on July 30, 2018
• Recall Number: Z-1630-2018
• Recall Event ID: 79765
• 510(K)Number: K101793
• Product Classification: Dressing, wound, drug - Product Code FRO
• Product: Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
• Code Information: Lot# 1610; 1621; 1639; 1737; 1745
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: 609-275-0500
• Manufacturer Reason for Recall: Incorrect gel part number listed in a master manufacturing record
• FDA Determined Cause: Manufacturing material removal
• Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated March, 6th, 2018 to distributor. The letter identified the affected product problem and actions to be taken. The letter instruct to complete and return the recall Acknowledgement form. For questions contact Customer Service at 1-800-854-2873. .
• Quantity in Commerce: 766 cases
• Distribution: US state of RI
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRO