FDA recall Z-1907-2020

Product

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.

Reason for recall

During an FDA audit, it was discovered that the product was not properly registered with FDA.

Distribution

Worldwide distribution - US Nationwide distributions and the country of South Africa.

Key facts

Status

Ongoing

Initiation date

2020-03-26

Report date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bristol, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1907-2020