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U.S. Department of Health and Human Services

Class 2 Device Recall Manuka Honey Wound Gel

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  Class 2 Device Recall Manuka Honey Wound Gel see related information
Date Initiated by Firm March 06, 2018
Create Date May 04, 2018
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = DERMA SCIENCES, INC.
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