Device 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.
Z-1909-2020
Product summary
- Firm
- Gentell, Inc
- Event
- Event 85373
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,348
- Official record key
device-enforcement:Z-1909-2020
Official wording
Reason: During an FDA audit, it was discovered that the product was not properly registered with FDA.
Code information: Lot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519
Distribution pattern: Worldwide distribution - US Nationwide distributions and the country of South Africa.
Derived failure modes
-
Unknown
During an FDA audit, it was discovered that the product was not properly registered with FDA.