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Class 2 Device Recall Honey Hydrogel |
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Date Initiated by Firm |
March 26, 2020 |
Create Date |
May 06, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1910-2020 |
Recall Event ID |
85373 |
Product Classification |
Dressing, wound, drug - Product Code FRO
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Product |
Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - 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 1105819 1107119 1110619 1118219 1121119 1122119 1130319 |
Recalling Firm/ Manufacturer |
Gentell, Inc 2701 Bartram Rd Bristol PA 19007-6810
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For Additional Information Contact |
SAME 800-840-9041
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Manufacturer Reason for Recall |
During an FDA audit, it was discovered that the product was not properly registered with FDA.
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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 |
4,419 |
Distribution |
Worldwide distribution - US Nationwide distributions and the country of South Africa. |
Total Product Life Cycle |
TPLC Device Report
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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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