Z-1908-2020 Class II Ongoing
FDA device recall Z-1908-2020 was initiated by Gentell, Inc on Mar 26, 2020 and is designated Class II. Reason for recall: During an FDA audit, it was discovered that the product was not properly registered with FDA. The recall status is ongoing. Affected quantity: 22,439.
Recall details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- Mar 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,439
Product description
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
Reason for recall
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Distribution pattern
Worldwide distribution - US Nationwide distributions and the country of South Africa.
Code information
Lot Numbers: 1133718 1135318 1101019 1102819 1105819 1107119 1110619 1116219 1118219 1121119 1122119 1123519 1126319 1130319
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1908-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026