FDAFDA · Food and drugs·Recall number Z-1907-2020
Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - 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.
Published May 13, 2020 · Recall initiated: March 26, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
During an FDA audit, it was discovered that the product was not properly registered with FDA.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gentell, Inc
- Distributor
- Worldwide distribution - US Nationwide distributions and the country of South Africa.
- Lot
- Lot Numbers: 1133718 1135318 1101019 1102819 1105819 1107119 1110619 1116219 1118219 1121119 1122119 1123519 1126319 1130319
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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