Recall Z-1908-2020
Gentell, Inc · initiated March 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - 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
Codes / lots: Lot Numbers: 1133718 1135318 1101019 1102819 1105819 1107119 1110619 1116219 1118219 1121119 1122119 1123519 1126319 1130319
Reason for recall
During an FDA audit, it was discovered that the product was not properly registered with FDA.
FDA-determined 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
Details
- Recall number
- Z-1908-2020
- Initiated
- March 26, 2020
- Product code
- FRO – Dressing, Wound, Drug
- Quantity
- 22,439
- Distribution
- Worldwide distribution - US Nationwide distributions and the country of South Africa.
- Recalling firm
- Gentell, Inc, Bristol, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1907-2020 Class II | Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing…During an FDA audit, it was discovered that the product was not properly registered with FDA. | 03/26/2020Open, Classified |
| Z-1909-2020 Class II | Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing…During an FDA audit, it was discovered that the product was not properly registered with FDA. | 03/26/2020Open, Classified |
| Z-1910-2020 Class II | Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey…During an FDA audit, it was discovered that the product was not properly registered with FDA. | 03/26/2020Open, Classified |