Z-1909-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- March 26, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,348
Product Description
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.
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 1110619 1116219 1118219 1121119 1122119 1123519