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.
- Company
- Gentell, Inc
- Recall Initiated
- March 26, 2020
- Recall Number
- Z-1909-2020
- Quantity
- 4,348
- Firm Location
- Bristol, PA
Reason for Recall
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Distribution
Worldwide distribution - US Nationwide distributions and the country of South Africa.
Lot / Code Info
Lot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519
Root Cause
No Marketing Application
Action Taken
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