Recall Z-1908-2020— Gentell, Inc
Class II · Ongoing
Class II FDA medical device recall by Gentell, Inc, initiated 2020-03-26. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: During an FDA audit, it was discovered that the product was not properly registered with FDA..
- Recalling firm
- Gentell, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-03-26
- Firm location
- Bristol, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.