Recall Z-1908-2020 ยท FRO Dressing, Wound, Drug
Gentell, Inc
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
| Date | Mar 26, 2020 |
| Status | Open, Classified |
| Reason | During an FDA audit, it was discovered that the product was not properly registered with FDA. |
| Root cause | 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 |
| Quantity | 22,439 |
| Distribution | Worldwide distribution - US Nationwide distributions and the country of South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.