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U.S. Department of Health and Human Services

Class 2 Device Recall Honey Hydrogel

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  Class 2 Device Recall Honey Hydrogel see related information
Date Initiated by Firm March 26, 2020
Create Date May 06, 2020
Recall Status1 Open3, Classified
Recall Number Z-1909-2020
Recall Event ID 85373
Product Classification Dressing, wound, drug - Product Code FRO
Product Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions.
Code Information Lot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519
Recalling Firm/
Manufacturer		 Gentell, Inc
2701 Bartram Rd
Bristol PA 19007-6810
For Additional Information Contact SAME
800-840-9041
Manufacturer Reason
for Recall		 During an FDA audit, it was discovered that the product was not properly registered with FDA.
FDA Determined
Cause 2		 No Marketing Application
Action Gentell issued Urgent Medical Device Recall letter dated 3/26/20 mailed March 27, 2020 via first class US Mail stating reason for recall, health risk and action to take: 1.If you have the affected stock, discontinue use and quarantine the products that contain any of the listed lot numbers. 2. To return product, complete the enclosed "Acknowledgement and Receipt Form" and fax to 215-788-2715 or email to vfalkenberg@gentell.com. A quality representative will contact you with a return goods authorization number (RGA#), provide instruction for the return of the product(s) to Gentell, and arrange for any refund that may be due. 3. If you have no affected stock, please complete the enclosed "Recall Acknowledgement Form" and fax to 215-788-2715 or email to vfalkenberg@gentell.com. This will allow us to verify receipt of this letter
Quantity in Commerce 4,348
Distribution Worldwide distribution - US Nationwide distributions and the country of South Africa.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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