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.
Reported: May 13, 2020 Initiated: March 26, 2020 #Z-1909-2020
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.
Details
- Recalling Firm
- Gentell, Inc
- Units Affected
- 4,348
- Distribution
- Worldwide distribution - US Nationwide distributions and the country of South Africa.
- Location
- Bristol, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Gentell, Inc. Units affected: 4,348.
Why was this product recalled? ▼
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 13, 2020. Severity: Moderate. Recall number: Z-1909-2020.
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